Register entryShortage reported

Amneal Ireland Limited

Data as of · How to read this entry

Registered sites
1
Active NDC listings
513
Labeller names
2
Live patents
34
Shortage listings
20
Countries
1
Base
Ireland
Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1Repackaging1
Sites

Registered establishments

1
EstablishmentAddressRegistered forFEI / DUNS
Amneal Ireland LimitedCahir Road, Cashel, E25 XD51 , Ireland (IRL)Analytical testing, Labelling, Finished drug manufacture, Packaging, Repackaging3012344329985619862
Alert

Drug shortage listings

20
DrugPresentationStatusAvailabilityPosted / updated
Dexmedetomidine Hydrochloride InjectionAnesthesiaDexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1389-7)CurrentAvailable10 Apr 202017 Jun 2026
Dexmedetomidine Hydrochloride InjectionAnesthesiaDexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 50 mL (NDC 70121-1388-1)CurrentAvailable10 Apr 202017 Jun 2026
Dexmedetomidine Hydrochloride InjectionAnesthesiaDexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 100 mL (NDC 70121-1389-1)CurrentAvailable10 Apr 202017 Jun 2026
Dexmedetomidine Hydrochloride InjectionAnesthesiaDexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1388-8)CurrentAvailable10 Apr 202017 Jun 2026
Lisdexamfetamine Dimesylate CapsulePsychiatryLisdexamfetamine Dimesylate, Capsule, 60 mg (NDC 65162-027-09)CurrentAvailable14 Jul 202317 Jun 2026
Lisdexamfetamine Dimesylate CapsulePsychiatryLisdexamfetamine Dimesylate, Capsule, 30 mg (NDC 65162-024-09)CurrentAvailable14 Jul 202317 Jun 2026
Lisdexamfetamine Dimesylate CapsulePsychiatryLisdexamfetamine Dimesylate, Capsule, 70 mg (NDC 65162-028-09)CurrentAvailable14 Jul 202317 Jun 2026
Lisdexamfetamine Dimesylate CapsulePsychiatryLisdexamfetamine Dimesylate, Capsule, 20 mg (NDC 65162-023-09)CurrentAvailable14 Jul 202317 Jun 2026
Lisdexamfetamine Dimesylate CapsulePsychiatryLisdexamfetamine Dimesylate, Capsule, 40 mg (NDC 65162-025-09)CurrentAvailable14 Jul 202317 Jun 2026
Lisdexamfetamine Dimesylate CapsulePsychiatryLisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 65162-026-09)CurrentAvailable14 Jul 202317 Jun 2026
Methylprednisolone Acetate InjectionRheumatologyMethylprednisolone Acetate, Injection, 40 mg/1 mL (NDC 70121-1573-5)CurrentAvailable15 Dec 202117 Jun 2026
Methylprednisolone Acetate InjectionRheumatologyMethylprednisolone Acetate, Injection, 80 mg/1 mL (NDC 70121-1574-1)CurrentAvailable15 Dec 202117 Jun 2026
Methylprednisolone Acetate InjectionRheumatologyMethylprednisolone Acetate, Injection, 80 mg/1 mL (NDC 70121-1574-5)CurrentAvailable15 Dec 202117 Jun 2026
Methylprednisolone Acetate InjectionRheumatologyMethylprednisolone Acetate, Injection, 40 mg/1 mL (NDC 70121-1573-1)CurrentLimited Availability15 Dec 202117 Jun 2026
Donepezil Hydrochloride; Memantine Hydrochloride Capsule, Extended ReleaseNeurologyDonepezil Hydrochloride; Memantine Hydrochloride, Capsule, Extended Release, 10 mg; 28 mg (NDC 69238-1247-3)To Be Discontinued-15 Jun 202615 Jun 2026
Donepezil Hydrochloride; Memantine Hydrochloride Capsule, Extended ReleaseNeurologyDonepezil Hydrochloride; Memantine Hydrochloride, Capsule, Extended Release, 10 mg; 14 mg (NDC 69238-1248-3)To Be Discontinued-15 Jun 202615 Jun 2026
Nitrofurantoin Oral SuspensionAnti-Infective, OtherNitrofurantoin, Oral Suspension, 25 mg/5 mL (NDC 69238-2512-9)To Be Discontinued-10 Apr 202610 Apr 2026
Dapsone GelDermatologyDapsone, Gel, 7.5% (NDC 69238-1627-6)To Be Discontinued-27 Mar 202627 Mar 2026
Clindamycin Palmitate Hydrochloride InjectionAnti-InfectiveClindamycin Palmitate Hydrochloride, Injection, 75 mg/5 mL (NDC 53746-468-19)To Be Discontinued-26 Mar 202626 Mar 2026
Sodium Oxybate SolutionPsychiatrySodium Oxybate, Solution, .5 g/1 mL (NDC 69238-2391-1)To Be Discontinued-29 Dec 202529 Dec 2025
Catalogue

Drug listings by form and route

513

513 active NDC listings: 499 human prescription drug, 14 human otc drug. By marketing category: ANDA 447, NDA 51, BLA 9, UNAPPROVED DRUG OTHER 6.

Dosage formNDCs
tablet117
injection53
injection, solution53
capsule46
tablet, film coated43
tablet, extended release28
solution17
capsule, extended release16
injection, suspension16
tablet, film coated, extended release14
kit12
injection, powder, lyophilized, for solution10
patch, extended release10
capsule, liquid filled8
injection, powder, for solution7
RouteNDCs
oral324
intravenous120
intramuscular45
intra-articular23
subcutaneous21
transdermal14
intrathecal12
topical9
intralesional8
soft tissue8
intravascular6
rectal6
epidural4
infiltration4
intracavitary4
Labeller name on the listingNDCs
amneal pharmaceuticals llc486
amneal pharmaceuticals private limited27
Exclusivity

Patents and exclusivities

34
PatentProductCoversExpiry
8907099ONGENTYSopicaponesubstanceMay 2027
8168793ONGENTYSopicaponesubstance, productOct 2027
9745290ONGENTYSopicaponeproductOct 2027
8524746ONGENTYSopicaponeuseJul 2029
10071085ONGENTYSopicaponeproductMar 2030
10583130ONGENTYSopicaponeuseMar 2030
12129247ONGENTYSopicaponeuseJan 2032
9630955ONGENTYSopicaponesubstance, productDec 2032
9855335TIGECYCLINEtigecyclineproductApr 2033
10881617PYRIDOSTIGMINE BROMIDEpyridostigmine bromideproductJun 2038
10925833PYRIDOSTIGMINE BROMIDEpyridostigmine bromideproductJun 2038
10987311PYRIDOSTIGMINE BROMIDEpyridostigmine bromideproductJun 2038
11229606PYRIDOSTIGMINE BROMIDEpyridostigmine bromideproductJun 2038
11478425PYRIDOSTIGMINE BROMIDEpyridostigmine bromideproductJun 2038
11666536PYRIDOSTIGMINE BROMIDEpyridostigmine bromideproductJun 2038
11911515PYRIDOSTIGMINE BROMIDEpyridostigmine bromideproductJun 2038
12042559PYRIDOSTIGMINE BROMIDEpyridostigmine bromideproductJun 2038
12233166PYRIDOSTIGMINE BROMIDEpyridostigmine bromideproductJun 2038
10532049BREKIYA (AUTOINJECTOR)dihydroergotamine mesylateproductFeb 2039
11304942BREKIYA (AUTOINJECTOR)dihydroergotamine mesylateproductFeb 2039
11819501BREKIYA (AUTOINJECTOR)dihydroergotamine mesylateuseFeb 2039
12533351BREKIYA (AUTOINJECTOR)dihydroergotamine mesylateproductFeb 2039
11541043BREKIYA (AUTOINJECTOR)dihydroergotamine mesylateproductMar 2039
12329749BREKIYA (AUTOINJECTOR)dihydroergotamine mesylateproductMay 2039
11083712BREKIYA (AUTOINJECTOR)dihydroergotamine mesylateproductJun 2039
12414941BREKIYA (AUTOINJECTOR)dihydroergotamine mesylateproductAug 2039
Catalogue

Marketed products

513

Showing 150 of 513.

BrandGeneric nameForm / routeNDC
ABIRATERONE ACETATEABIRATERONEtablet, oral60219-1754ANDA
ALBENZAalbendazoletablet, film coated, oral64896-693NDA
ALYMSYSbevacizumab-malyinjection, solution, intravenous70121-1754BLA
ALYMSYSbevacizumab-malyinjection, solution, intravenous70121-1755BLA
ATOVAQUONEATOVAQUONEsuspension, oral65162-693ANDA
AZACITIDINEAZACITIDINEinjection, powder, lyophilized, for solution, intravenous, subcutaneous70121-1237ANDA
Abiraterone AcetateAbirateronetablet, oral60219-1165ANDA
Acebutolol HydrochlorideAcebutolol Hydrochloridecapsule, oral65162-669ANDA
Acebutolol HydrochlorideAcebutolol Hydrochloridecapsule, oral65162-670ANDA
Acetaminophen and CodeineAcetaminophen and Codeinetablet, oral65162-033ANDA
ActivellaEstradiol/norethindrone acetatetablet, film coated, oral60846-231NDA
ActivellaEstradiol/norethindrone acetatetablet, film coated, oral60846-232NDA
AcyclovirAcyclovirointment, topical65162-835ANDA
AcyclovirAcyclovircream, topical65162-836ANDA
Alosetron HydrochlorideAlosetron Hydrochloridetablet, film coated, oral65162-248ANDA
Alosetron HydrochlorideAlosetron Hydrochloridetablet, film coated, oral65162-249ANDA
AlprazolamAlprazolamtablet, extended release, oral65162-809ANDA
AlprazolamAlprazolamtablet, extended release, oral65162-810ANDA
AlprazolamAlprazolamtablet, extended release, oral65162-812ANDA
AlprazolamAlprazolamtablet, extended release, oral65162-813ANDA
Aminocaproic acidAminocaproic acidtablet, oral69238-1637ANDA
ArgatrobanArgatrobaninjection, solution, intravenous70121-1037ANDA
AripiprazoleAripiprazolesolution, oral65162-893ANDA
AripiprazoleAripiprazoletablet, oral65162-896ANDA
AripiprazoleAripiprazoletablet, oral65162-897ANDA
AripiprazoleAripiprazoletablet, oral65162-898ANDA
AripiprazoleAripiprazoletablet, oral65162-899ANDA
AripiprazoleAripiprazoletablet, oral65162-901ANDA
AripiprazoleAripiprazoletablet, oral65162-902ANDA
Arsenic TrioxideArsenic Trioxideinjection, solution, intravenous70121-1483ANDA
Arsenic TrioxideArsenic Trioxideinjection, solution, intravenous70121-1658ANDA
Aspirin and Extended-Release DipyridamoleAspirin and Extended-Release Dipyridamolecapsule, oral65162-596ANDA
Azelastine HydrochlorideAzelastinespray, metered, nasal65162-676ANDA
BORUZUBortezomibinjection, intravenous, subcutaneous70121-2484NDA
BREKIYADihydroergotamine Mesylateinjection, subcutaneous64896-509NDA
Benazepril HydrochlorideBenazepril Hydrochloridetablet, oral65162-751ANDA
Benazepril HydrochlorideBenazepril Hydrochloridetablet, oral65162-752ANDA
Benazepril HydrochlorideBenazepril Hydrochloridetablet, oral65162-753ANDA
Benazepril HydrochlorideBenazepril Hydrochloridetablet, oral65162-754ANDA
BenzonatateBenzonatatecapsule, liquid filled, oral65162-536ANDA
BenzonatateBenzonatatecapsule, liquid filled, oral65162-537ANDA
Bethanechol ChlorideBethanechol Chloridetablet, oral65162-571ANDA
Bethanechol ChlorideBethanechol Chloridetablet, oral65162-572ANDA
Bethanechol ChlorideBethanechol Chloridetablet, oral65162-573ANDA
Bethanechol ChlorideBethanechol Chloridetablet, oral65162-574ANDA
Boncresadenosumab-mobzinjection, solution, subcutaneous70121-2702BLA
BudesonideBudesonidecapsule, delayed release, oral65162-778ANDA
Buprenorphine HCl and Naloxone HClBuprenorphine and Naloxonetablet, sublingual65162-415ANDA
Buprenorphine HCl and Naloxone HClBuprenorphine and Naloxonetablet, sublingual65162-416ANDA
BusulfanBusulfaninjection, intravenous70121-1244ANDA
CALCIUM GLUCONATEcalcium gluconateinjection, solution, intravenous80830-2362ANDA
CALCIUM GLUCONATEcalcium gluconateinjection, solution, intravenous80830-2363ANDA
CREXONTcarbidopa and levodopacapsule, extended release, oral64896-967NDA
CREXONTcarbidopa and levodopacapsule, extended release, oral64896-968NDA
CREXONTcarbidopa and levodopacapsule, extended release, oral64896-969NDA
CREXONTcarbidopa and levodopacapsule, extended release, oral64896-970NDA
CUPRIC CHLORIDECUPRIC CHLORIDEinjection, solution, intravenous80830-2301ANDA
CalcitriolCalcitriolcapsule, oral65162-519ANDA
CalcitriolCalcitriolcapsule, oral65162-576ANDA
Cetirizine HydrochlorideCetirizinesolution, oral65162-003ANDA
Cetirizine HydrochlorideCetirizinesolution, oral65162-005ANDA
Cetirizine HydrochlorideCetirizinetablet, oral65162-045ANDA
Cetirizine HydrochlorideCetirizinetablet, oral65162-046ANDA
Cetirizine HydrochlorideCetirizinesolution, oral65162-684ANDA
Cetirizine Hydrochloride Hives ReliefCetirizinetablet, oral65162-145ANDA
ChlorthalidoneChlorthalidonetablet, oral65162-247ANDA
ChlorthalidoneChlorthalidonetablet, oral65162-250ANDA
Cinacalcet HydrochlorideCinacalcettablet, oral65162-155ANDA
Cinacalcet HydrochlorideCinacalcettablet, oral65162-157ANDA
Cinacalcet HydrochlorideCinacalcettablet, oral65162-213ANDA
CitalopramCitalopramtablet, oral65162-052ANDA
CitalopramCitalopramtablet, oral65162-053ANDA
CitalopramCitalopramtablet, oral65162-054ANDA
Clindamycin Palmitate Hydrochloride (Pediatric)Clindamycin Palmitate Hydrochloridepowder, for solution, oral65162-468ANDA
Clobetasol PropionateClobetasol Propionatecream, topical69238-1532ANDA
ClofarabineClofarabineinjection, intravenous70121-1236ANDA
ClopidogrelClopidogreltablet, oral65162-414ANDA
ColchicineColchicinetablet, oral65162-710ANDA
Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloridetablet, film coated, oral65162-540ANDA
Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloridetablet, film coated, oral65162-541ANDA
CyclophosphamideCyclophosphamideinjection, powder, for solution, intravenous, oral70121-1238ANDA
CyclophosphamideCyclophosphamideinjection, powder, for solution, intravenous, oral70121-1239ANDA
CyclophosphamideCyclophosphamideinjection, powder, for solution, intravenous, oral70121-1240ANDA
DEXEDRINE SPANSULEdextroamphetamine sulfatecapsule, extended release, oral64896-673NDA
DEXEDRINE SPANSULEdextroamphetamine sulfatecapsule, extended release, oral64896-674NDA
DEXEDRINE SPANSULEdextroamphetamine sulfatecapsule, extended release, oral64896-675NDA
DOTTIEstradiolpatch, extended release, transdermal65162-989ANDA
DOTTIEstradiolpatch, extended release, transdermal65162-992ANDA
DOTTIEstradiolpatch, extended release, transdermal65162-993ANDA
DOTTIEstradiolpatch, extended release, transdermal65162-995ANDA
DOTTIEstradiolpatch, extended release, transdermal65162-997ANDA
DapsoneDapsonegel, topical65162-339ANDA
Decitabinedecitabineinjection, powder, lyophilized, for solution, intravenous70121-1644ANDA
Demeclocycline HydrochlorideDemeclocyclinetablet, oral65162-554ANDA
Demeclocycline HydrochlorideDemeclocyclinetablet, oral65162-555ANDA
Desipramine HydrochlorideDesipraminetablet, film coated, oral69238-1053ANDA
Desipramine HydrochlorideDesipraminetablet, film coated, oral69238-1055ANDA
Desipramine HydrochlorideDesipraminetablet, film coated, oral69238-1057ANDA
Desipramine HydrochlorideDesipraminetablet, film coated, oral69238-1059ANDA
Desipramine HydrochlorideDesipraminetablet, film coated, oral69238-1061ANDA
Desipramine HydrochlorideDesipraminetablet, film coated, oral69238-1063ANDA
Dexamethasone Sodium PhosphateDexamethasone Sodium Phosphateinjection, solution, intramuscular, intravenous70121-1399ANDA
Dexamethasone Sodium PhosphateDexamethasone Sodium Phosphateinjection, solution, intra-articular, intralesional, intramuscular, intravenous, soft tissue70121-1450ANDA
Dexamethasone Sodium PhosphateDexamethasone Sodium Phosphateinjection, solution, intra-articular, intralesional, intramuscular, intravenous, soft tissue70121-1451ANDA
Dexamethasone Sodium PhosphateDexamethasone Sodium Phosphateinjection, solution, intra-articular, intralesional, intramuscular, intravenous, soft tissue70121-1452ANDA
Dexmedetomidine HydrochlorideDexmedetomidine Hydrochlorideinjection, solution, intravenous70121-1388ANDA
Dexmedetomidine HydrochlorideDexmedetomidine Hydrochlorideinjection, solution, intravenous70121-1389ANDA
Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride in Sodium Chlorideinjection, intravenous70121-1711ANDA
Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride in Sodium Chlorideinjection, intravenous70121-1712ANDA
Dextromethorphan Polistirex Extended-ReleaseDextromethorphan Polistirexsuspension, oral65162-700ANDA
Dextromethorphan Polistirex Extended-ReleaseDextromethorphan Polistirexsuspension, oral65162-799ANDA
Diclofenac SodiumDiclofenacsolution, topical65162-683ANDA
Diclofenac SodiumDiclofenacsolution, topical65162-911ANDA
Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostoltablet, delayed release, oral65162-436ANDA
Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostoltablet, delayed release, oral65162-438ANDA
DifluprednateDifluprednate ophthalmicemulsion, ophthalmic69238-1380ANDA
Divalproex SodiumDivalproex Sodiumtablet, extended release, oral65162-755ANDA
Divalproex SodiumDivalproex Sodiumtablet, extended release, oral65162-757ANDA
DocetaxelDocetaxelinjection, intravenous70121-1221ANDA
DocetaxelDocetaxelinjection, intravenous70121-1222ANDA
DocetaxelDocetaxelinjection, intravenous70121-1223ANDA
Doxepin HydrochlorideDoxepin Hydrochloridecapsule, oral69238-1166ANDA
Doxepin HydrochlorideDoxepin Hydrochloridecapsule, oral69238-1170ANDA
Doxepin HydrochlorideDoxepin Hydrochloridecapsule, oral69238-1171ANDA
Doxepin HydrochlorideDoxepin Hydrochloridecapsule, oral69238-1172ANDA
Doxepin HydrochlorideDoxepin Hydrochloridecapsule, oral69238-1173ANDA
Doxorubicin HydrochlorideDoxorubicininjection, powder, lyophilized, for solution, intravenous70121-1218ANDA
Doxorubicin HydrochlorideDoxorubicin Hydrochlorideinjection, powder, lyophilized, for solution, intravenous70121-1219ANDA
DoxycyclineDoxycyclineinjection, powder, lyophilized, for solution, intravenous70121-1616ANDA
DutasterideDutasteridecapsule, oral65162-750ANDA
EPINEPHRINEepinephrineinjection, intramuscular, intravenous, subcutaneous80830-1659ANDA
EluRyngEtonogestrel and Ethinyl Estradiolring, vaginal65162-469ANDA
EntecavirEntecavirtablet, film coated, oral65162-446ANDA
EntecavirEntecavirtablet, film coated, oral65162-449ANDA
Ephedrine SulfateEphedrine Sulfateinjection, intravenous70121-1637ANDA
Escitalopram OxalateEscitalopram Oxalatetablet, film coated, oral65162-019ANDA
Escitalopram OxalateEscitalopram Oxalatetablet, film coated, oral65162-020ANDA
Escitalopram OxalateEscitalopram Oxalatetablet, film coated, oral65162-021ANDA
Escitalopram OxalateEscitalopramsolution, oral65162-705ANDA
Esmolol HydrochlorideEsmolol Hydrochloride in Sodium Chlorideinjection, intravenous70121-1716ANDA
Esmolol HydrochlorideEsmolol Hydrochloride in Sodium Chlorideinjection, intravenous70121-1717ANDA
ExenatideExenatideinjection, subcutaneous70121-1685ANDA
ExenatideExenatideinjection, subcutaneous70121-1686ANDA
Extended Phenytoin SodiumPhenytoin Sodiumcapsule, oral65162-212ANDA
FENOFIBRATEFENOFIBRATEtablet, oral60219-5511ANDA
FENOFIBRATEFENOFIBRATEtablet, oral60219-5522ANDA
FOCINVEZFOSAPREPITANT DIMEGLUMINEinjection, intravenous70121-2631NDA
FYLNETRApegfilgrastiminjection, subcutaneous70121-1627BLA
FelbamateFelbamatesuspension, oral65162-686ANDA
FelbamateFelbamatetablet, oral65162-734ANDA
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Enquiry

Common questions

Is Amneal Ireland Limited FDA approved?
Amneal Ireland Limited holds 1 FDA-registered establishment in Ireland. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Amneal Ireland Limited's drugs manufactured?
The FDA register lists Cashel. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, repackaging.
What drugs does Amneal Ireland Limited make?
513 products are listed under Amneal Ireland Limited in the openFDA NDC Directory, most often as tablet; injection; injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Are any Amneal Ireland Limited products in shortage?
14 presentations are currently listed in the FDA drug shortage database under Amneal Ireland Limited, covering Dexmedetomidine Hydrochloride Injection, Lisdexamfetamine Dimesylate Capsule, Methylprednisolone Acetate Injection.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.