Register entryShortage reported

ACCORD HEALTHCARE LIMITED

Data as of · How to read this entry

Registered sites
2
Active NDC listings
242
Labeller names
8
Live patents
10
Exclusivities
1
Shortage listings
25
Countries
1
Base
United Kingdom
Authorisation

Registered operations

Analytical testing2Finished drug manufacture1Packaging2
Sites

Registered establishments

2
EstablishmentAddressRegistered forFEI / DUNS
ACCORD-UK LTDWhiddon Valley, Whiddon Valley Industrial Estate, Barnstaple, Devon EX32 8NS, United Kingdom (GBR)Analytical testing, Finished drug manufacture, Packaging3006750335216045922
ACCORD HEALTHCARE LIMITEDEDGEFIELD AVE, NEWCASTLE UPON TYNE, NE3 3NB, United Kingdom (GBR)Analytical testing, Packaging3026277693229441106
Alert

Drug shortage listings

25
DrugPresentationStatusAvailabilityPosted / updated
Atropine Sulfate InjectionAnesthesia, Neurology, PediatricAtropine Sulfate, Injection, 0.1 mg/1 mL (NDC 16729-484-45)CurrentAvailable1 Jan 202015 Sept 2026
Atropine Sulfate InjectionAnesthesia, Neurology, PediatricAtropine Sulfate, Injection, .05 mg/1 mL (NDC 16729-483-03)CurrentUnavailable1 Jan 202015 Sept 2026
Atropine Sulfate InjectionAnesthesia, Neurology, PediatricAtropine Sulfate, Injection, .1 mg/1 mL (NDC 16729-484-90)CurrentUnavailable1 Jan 202015 Sept 2026
Azacitidine InjectionOncologyAzacitidine, Injection, 100 mg (NDC 16729-306-10)CurrentAvailable21 Dec 202015 Sept 2026
Carboplatin InjectionOncologyCarboplatin, Injection, 10 mg/1 mL (NDC 16729-295-12)CurrentUnavailable28 Apr 202315 Sept 2026
Carboplatin InjectionOncologyCarboplatin, Injection, 10 mg/1 mL (NDC 16729-295-33)CurrentUnavailable28 Apr 202315 Sept 2026
Carboplatin InjectionOncologyCarboplatin, Injection, 10 mg/1 mL (NDC 16729-295-31)CurrentUnavailable28 Apr 202315 Sept 2026
Carboplatin InjectionOncologyCarboplatin, Injection, 10 mg/1 mL (NDC 16729-295-34)CurrentUnavailable28 Apr 202315 Sept 2026
Clonazepam TabletNeurology, Pediatric, PsychiatryClonazepam, Tablet, 2 mg (NDC 16729-138-00)CurrentAvailable10 Mar 202315 Sept 2026
Clonazepam TabletNeurology, Pediatric, PsychiatryClonazepam, Tablet, 1 mg (NDC 16729-137-16)CurrentAvailable10 Mar 202315 Sept 2026
Clonazepam TabletNeurology, Pediatric, PsychiatryClonazepam, Tablet, .5 mg (NDC 16729-136-00)CurrentAvailable10 Mar 202315 Sept 2026
Clonazepam TabletNeurology, Pediatric, PsychiatryClonazepam, Tablet, .5 mg (NDC 16729-136-16)CurrentAvailable10 Mar 202315 Sept 2026
Clonazepam TabletNeurology, Pediatric, PsychiatryClonazepam, Tablet, 1 mg (NDC 16729-137-00)CurrentAvailable10 Mar 202315 Sept 2026
Clonazepam TabletNeurology, Pediatric, PsychiatryClonazepam, Tablet, 2 mg (NDC 16729-138-16)CurrentAvailable10 Mar 202315 Sept 2026
Dexmedetomidine Hydrochloride InjectionAnesthesiaDexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93)CurrentUnavailable10 Apr 202015 Sept 2026
Dexmedetomidine Hydrochloride InjectionAnesthesiaDexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-432-93)CurrentUnavailable10 Apr 202015 Sept 2026
Furosemide InjectionCardiovascularFurosemide, Injection, 10 mg/1 mL (NDC 16729-501-43)CurrentUnavailable7 Apr 202015 Sept 2026
Furosemide InjectionCardiovascularFurosemide, Injection, 10 mg/1 mL (NDC 16729-500-08)CurrentUnavailable7 Apr 202015 Sept 2026
Furosemide InjectionCardiovascularFurosemide, Injection, 10 mg/1 mL (NDC 16729-502-43)CurrentUnavailable7 Apr 202015 Sept 2026
Methotrexate Sodium InjectionRheumatology, OncologyMethotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 16729-277-30)CurrentUnavailable13 Mar 202315 Sept 2026
Methotrexate Sodium InjectionRheumatology, OncologyMethotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 16729-277-35)CurrentUnavailable13 Mar 202315 Sept 2026
Atropine Sulfate InjectionAnesthesia, Neurology, PediatricAtropine Sulfate, Injection, 1 mg/1 mL (NDC 16729-526-08)CurrentUnavailable1 Jan 20121 Sept 2026
Atropine Sulfate InjectionAnesthesia, Neurology, PediatricAtropine Sulfate, Injection, .4 mg/1 mL (NDC 16729-525-08)CurrentUnavailable1 Jan 20121 Sept 2026
Atropine Sulfate InjectionAnesthesia, Neurology, PediatricAtropine Sulfate, Injection, .4 mg/1 mL (NDC 16729-512-43)CurrentUnavailable1 Jan 20121 Sept 2026
Dehydrated Alcohol Injection, SolutionCardiovascularDehydrated Alcohol, Injection, Solution, 1 mL/1 mL (10 pack) (NDC 16729-710-45)To Be Discontinued-27 May 202627 May 2026
Catalogue

Drug listings by form and route

242

242 active NDC listings: 238 human prescription drug, 4 drug for further processing. By marketing category: ANDA 220, BLA 12, NDA 6, DRUG FOR FURTHER PROCESSING 4.

Dosage formNDCs
tablet, film coated71
tablet66
injection24
capsule20
injection, powder, lyophilized, for solution18
injection, solution14
tablet, extended release12
capsule, extended release4
capsule, delayed release2
injection, emulsion2
injection, solution, concentrate2
ointment2
tablet, delayed release2
cream1
kit1
RouteNDCs
oral172
intravenous49
subcutaneous13
intramuscular11
topical3
sublingual2
endotracheal1
intra-arterial1
intramedullary1
intrathecal1
percutaneous1
Labeller name on the listingNDCs
accord healthcare inc.143
accord healthcare, inc.67
accord healthcare, inc.,10
accord biopharma inc.9
accord biopharma, inc.5
accord healthcare inc3
accord healthcare, inc3
accord biopharma inc.,2
Exclusivity

Patents and exclusivities

10
PatentProductCoversExpiry
10646572CAMCEVI ETM, CAMCEVI KITleuprolide mesylateproductJan 2027
9744207CAMCEVI ETM, CAMCEVI KITleuprolide mesylateproductJan 2027
9572857CAMCEVI ETM, CAMCEVI KITleuprolide mesylateproductAug 2029
12133878CAMCEVI ETM, CAMCEVI KITleuprolide mesylateproductDec 2037
11717555CAMCEVI ETM, CAMCEVI KITleuprolide mesylateproductJan 2039
ProductExclusivityUntil
CAMCEVI ETMLEUPROLIDE MESYLATENS New strengthAug 2028
Catalogue

Marketed products

242

Showing 150 of 242.

BrandGeneric nameForm / routeNDC
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEtablet, film coated, oral16729-171ANDA
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEtablet, film coated, oral16729-175ANDA
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEtablet, film coated, oral16729-176ANDA
ARGATROBANArgatrobaninjection, intravenous16729-430NDA
ARIPIPRAZOLEARIPIPRAZOLEtablet, oral16729-278ANDA
ARIPIPRAZOLEARIPIPRAZOLEtablet, oral16729-279ANDA
ARIPIPRAZOLEARIPIPRAZOLEtablet, oral16729-280ANDA
ARIPIPRAZOLEARIPIPRAZOLEtablet, oral16729-281ANDA
ARIPIPRAZOLEARIPIPRAZOLEtablet, oral16729-282ANDA
ARIPIPRAZOLEARIPIPRAZOLEtablet, oral16729-283ANDA
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMtablet, film coated, oral16729-044ANDA
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMtablet, film coated, oral16729-045ANDA
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMtablet, film coated, oral16729-046ANDA
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMtablet, film coated, oral16729-047ANDA
ATROPINE SULFATEATROPINE SULFATEinjection, intravenous16729-483ANDA
ATROPINE SULFATEATROPINE SULFATEinjection, intravenous16729-484ANDA
Allopurinolallopurinoltablet, oral16729-134ANDA
AllopurinolALLOPURINOLtablet, oral16729-135ANDA
AnastrozoleAnastrozoletablet, oral16729-035ANDA
Atropine SulfateAtropine Sulfateinjection, solution, endotracheal, intramedullary, intramuscular, intravenous, subcutaneous16729-512ANDA
AzacitidineAzacitidineinjection, powder, lyophilized, for solution, intravenous, subcutaneous16729-306ANDA
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEtablet, sublingual16729-549ANDA
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEtablet, sublingual16729-550ANDA
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEtablet, extended release, oral16729-443ANDA
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEtablet, extended release, oral16729-444ANDA
BicalutamideBicalutamidetablet, oral16729-023ANDA
Bivalirudinbivalirudininjection, powder, lyophilized, for solution, intravenous16729-275ANDA
Buspirone HydrochlorideBuspirone Hydrochloridetablet, oral16729-200ANDA
Buspirone HydrochlorideBuspirone Hydrochloridetablet, oral16729-201ANDA
Buspirone HydrochlorideBuspirone Hydrochloridetablet, oral16729-202ANDA
Buspirone HydrochlorideBuspirone Hydrochloridetablet, oral16729-203ANDA
Buspirone HydrochlorideBuspirone Hydrochloridetablet, oral16729-289ANDA
Busulfanbusulfaninjection, intravenous16729-351ANDA
CAMCEVILEUPROLIDEinjection, emulsion, subcutaneous69448-014NDA
CAMCEVIleuprolideinjection, emulsion, subcutaneous69448-023NDA
CAPECITABINECAPECITABINEtablet, film coated, oral16729-072ANDA
CAPECITABINECAPECITABINEtablet, film coated, oral16729-073ANDA
CARBIDOPA AND LEVODOPACarbidopa and Levodopatablet, extended release, oral16729-078ANDA
CARBIDOPA AND LEVODOPACarbidopa and Levodopatablet, extended release, oral16729-079ANDA
CINACALCETCinacalcettablet, film coated, oral16729-440ANDA
CINACALCETCinacalcettablet, film coated, oral16729-441ANDA
CINACALCETCinacalcettablet, film coated, oral16729-442ANDA
CarboplatinCarboplatininjection, intravenous16729-295ANDA
CisplatinCisplatininjection, intravenous16729-288ANDA
Clomiphene CitrateClomiphene Citratetablet, oral16729-723ANDA
Clonazepamclonazepamtablet, oral16729-136ANDA
Clonazepamclonazepamtablet, oral16729-137ANDA
Clonazepamclonazepamtablet, oral16729-138ANDA
Clozapineclozapinetablet, oral16729-141ANDA
Clozapineclozapinetablet, oral16729-142ANDA
DAPTOMYCINDaptomycininjection, powder, lyophilized, for solution, intravenous16729-435ANDA
DEHYDRATED ALCOHOLALCOHOLinjection, solution, percutaneous16729-710ANDA
DIMETHYL FUMARATEDimethyl fumaratecapsule, delayed release, oral16729-416ANDA
DIMETHYL FUMARATEDimethyl fumaratecapsule, delayed release, oral16729-417ANDA
DOCETAXELdocetaxelinjection, solution, concentrate, intravenous16729-267NDA
DalfampridineDalfampridinetablet, film coated, extended release, oral16729-292ANDA
DaptomycinDaptomycininjection, powder, lyophilized, for solution, intravenous16729-434ANDA
Decitabinedecitabineinjection, powder, lyophilized, for solution, intravenous16729-224ANDA
DexmedetomidineDexmedetomidineinjection, solution, intravenous16729-239ANDA
Diltiazem HydrochlorideDiltiazem Hydrochloridecapsule, extended release, oral16729-303ANDA
Diltiazem HydrochlorideDiltiazem Hydrochloridecapsule, extended release, oral16729-304ANDA
Diltiazem HydrochlorideDiltiazem Hydrochloridecapsule, extended release, oral16729-305ANDA
DofetilideDofetilidecapsule, oral16729-490ANDA
DofetilideDofetilidecapsule, oral16729-491ANDA
DofetilideDofetilidecapsule, oral16729-492ANDA
DoxazosinDoxazosintablet, oral16729-211ANDA
DoxazosinDoxazosintablet, oral16729-213ANDA
DoxazosinDoxazosintablet, oral16729-414ANDA
DoxazosinDoxazosintablet, oral16729-415ANDA
EZETIMIBEEZETIMIBEtablet, oral16729-433ANDA
EplerenoneEplerenonetablet, film coated, oral16729-293ANDA
EplerenoneEplerenonetablet, film coated, oral16729-294ANDA
EscitalopramEscitalopramtablet, film coated, oral16729-168ANDA
EscitalopramEscitalopramtablet, film coated, oral16729-169ANDA
EscitalopramEscitalopramtablet, film coated, oral16729-170ANDA
EtoposideEtoposideinjection, intravenous16729-114ANDA
FILKRIfilgrastim-lahainjection, solution, intravenous, subcutaneous69448-008BLA
FILKRIfilgrastim-lahainjection, solution, intravenous, subcutaneous69448-009BLA
FINGOLIMOD HYDROCHLORIDEFINGOLIMOD HYDROCHLORIDEcapsule, oral16729-342ANDA
FULVESTRANTFulvestrantinjection, intramuscular16729-436ANDA
FinasterideFinasteridetablet, film coated, oral16729-089ANDA
Finasteridefinasteridetablet, film coated, oral16729-090ANDA
FluorouracilFluorouracilinjection, solution, intravenous16729-276ANDA
FluorouracilFluorouracilcream, topical16729-542ANDA
FurosemideFurosemideinjection, intramuscular, intravenous16729-500ANDA
FurosemideFurosemideinjection, intramuscular, intravenous16729-501ANDA
FurosemideFurosemideinjection, intramuscular, intravenous16729-502ANDA
GlimepirideGlimepiridetablet, oral16729-001ANDA
GlimepirideGlimepiridetablet, oral16729-002ANDA
GlimepirideGlimepiridetablet, oral16729-003ANDA
Glycopyrrolateglycopyrrolateinjection, intramuscular, intravenous16729-471ANDA
Glycopyrrolateglycopyrrolateinjection, intramuscular, intravenous16729-472ANDA
Glycopyrrolateglycopyrrolateinjection, intramuscular, intravenous16729-473ANDA
Glycopyrrolateglycopyrrolateinjection, intramuscular, intravenous16729-474ANDA
HERCESSITrastuzumab-strfinjection, powder, lyophilized, for solution, intravenous69448-015BLA
HERCESSITrastuzumab-strfinjection, powder, lyophilized, for solution, intravenous69448-016BLA
HydrochlorothiazideHydrochlorothiazidetablet, oral16729-182ANDA
HydrochlorothiazideHydrochlorothiazidetablet, oral16729-183ANDA
HydrochlorothiazideHydrochlorothiazidetablet, oral16729-184ANDA
Hydroxychloroquine SulfateHydroxychloroquine Sulfatetablet, oral16729-485ANDA
Hydroxychloroquine SulfateHydroxychloroquine Sulfatetablet, oral16729-561ANDA
Hydroxychloroquine SulfateHydroxychloroquine Sulfatetablet, oral16729-562ANDA
Hydroxychloroquine SulfateHydroxychloroquine Sulfatetablet, oral16729-563ANDA
IMULDOSAustekinumab-srlfinjection, subcutaneous69448-017BLA
IMULDOSAustekinumab-srlfinjection, subcutaneous69448-018BLA
IMULDOSAustekinumab-srlfinjection, intravenous69448-019BLA
JUBEREQdenosumab-desuinjection, subcutaneous69448-022BLA
LenalidomideLenalidomidecapsule, oral16729-692ANDA
LenalidomideLenalidomidecapsule, oral16729-693ANDA
LenalidomideLenalidomidecapsule, oral16729-694ANDA
LenalidomideLenalidomidecapsule, oral16729-695ANDA
LenalidomideLenalidomidecapsule, oral16729-696ANDA
LenalidomideLenalidomidecapsule, oral16729-697ANDA
Letrozoleletrozoletablet, film coated, oral16729-034ANDA
Levothyroxine sodiumLevothyroxine Sodiumtablet, oral16729-447ANDA
Levothyroxine sodiumLevothyroxine Sodiumtablet, oral16729-448ANDA
Levothyroxine sodiumLevothyroxine Sodiumtablet, oral16729-449ANDA
Levothyroxine sodiumLevothyroxine Sodiumtablet, oral16729-450ANDA
Levothyroxine sodiumLevothyroxine Sodiumtablet, oral16729-451ANDA
Levothyroxine sodiumLevothyroxine Sodiumtablet, oral16729-452ANDA
Levothyroxine sodiumLevothyroxine Sodiumtablet, oral16729-453ANDA
Levothyroxine sodiumLevothyroxine Sodiumtablet, oral16729-454ANDA
Levothyroxine sodiumLevothyroxine Sodiumtablet, oral16729-455ANDA
Levothyroxine sodiumLevothyroxine Sodiumtablet, oral16729-456ANDA
Levothyroxine sodiumLevothyroxine Sodiumtablet, oral16729-457ANDA
Levothyroxine sodiumLevothyroxine Sodiumtablet, oral16729-458ANDA
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEtablet, oral16729-478ANDA
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEtablet, oral16729-479ANDA
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEtablet, oral16729-480ANDA
MUTAMYCINMitomycininjection, powder, lyophilized, for solution, intravenous69448-001ANDA
MUTAMYCINMitomycininjection, powder, lyophilized, for solution, intravenous69448-003ANDA
MethotrexateMethotrexateinjection, intra-arterial, intramuscular, intrathecal, intravenous16729-277ANDA
MethotrexateMethotrexatetablet, oral16729-486ANDA
MitomycinMitomycininjection, powder, lyophilized, for solution, intravenous16729-108ANDA
MitomycinMitomycininjection, powder, lyophilized, for solution, intravenous16729-115ANDA
MitomycinMitomycininjection, powder, lyophilized, for solution, intravenous16729-116ANDA
Montelukast SodiumMontelukast Sodiumtablet, film coated, oral16729-119ANDA
Mycophenolic AcidMycophenolic Acidtablet, delayed release, oral16729-189ANDA
Mycophenolic AcidMycophenolic Acidtablet, delayed release, oral16729-261ANDA
Naltrexone HydrochlorideNaltrexone Hydrochloridetablet, film coated, oral16729-081ANDA
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEtablet, film coated, oral16729-366ANDA
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEtablet, film coated, oral16729-367ANDA
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEtablet, film coated, oral16729-368ANDA
OSVYRTIdenosumab-desuinjection, subcutaneous69448-021BLA
PEMETREXEDPemetrexedinjection, powder, lyophilized, for solution, intravenous16729-229ANDA
PEMETREXEDPemetrexedinjection, powder, lyophilized, for solution, intravenous16729-230ANDA
PEMETREXEDPemetrexedinjection, powder, lyophilized, for solution, intravenous16729-244ANDA
PIRFENIDONEPIRFENIDONEtablet, film coated, oral16729-467ANDA
PIRFENIDONEPIRFENIDONEtablet, film coated, oral16729-468ANDA
PRAVASTATIN SODIUMPRAVASTATIN SODIUMtablet, oral16729-008ANDA
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Enquiry

Common questions

Is ACCORD HEALTHCARE LIMITED FDA approved?
ACCORD HEALTHCARE LIMITED holds 2 FDA-registered establishments in the United Kingdom. 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 ACCORD HEALTHCARE LIMITED's drugs manufactured?
The FDA register lists Barnstaple; NEWCASTLE UPON TYNE. Registered operations: analytical testing, finished drug manufacture, packaging.
What drugs does ACCORD HEALTHCARE LIMITED make?
242 products are listed under ACCORD HEALTHCARE LIMITED in the openFDA NDC Directory, most often as tablet, film coated; tablet; injection. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Are any ACCORD HEALTHCARE LIMITED products in shortage?
24 presentations are currently listed in the FDA drug shortage database under ACCORD HEALTHCARE LIMITED, covering Atropine Sulfate Injection, Azacitidine Injection, Carboplatin Injection and 4 other drugs.

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.