Register entryShortage reported

Epic Laboratories, LLC

Data as of · How to read this entry

Registered sites
3
Active NDC listings
209
Labeller names
7
Live patents
0
Shortage listings
11
Countries
1
Base
United States
Authorisation

Registered operations

Labelling1Finished drug manufacture3Packaging1
Sites

Registered establishments

3
EstablishmentAddressRegistered forFEI / DUNS
Epic Pharma, LLC22715 North Conduit Avenue, Laurelton, New York (NY) 11413, United States (USA)Finished drug manufacture2431929827915443
Epic Laboratories, LLC8625 Florida Mining Blvd., Tampa, Florida (FL) 33634, United States (USA)Labelling, Finished drug manufacture, Packaging3010166225119307904
Epic Pharma, LLC609 Cantiague Rock Rd Unit 2, Westbury, New York (NY) 11590-1721, United States (USA)Finished drug manufacture3031887837119310573
Alert

Drug shortage listings

11
DrugPresentationStatusAvailabilityPosted / updated
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletPsychiatryAmphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg (NDC 42806-339-01)CurrentLimited Availability12 Oct 202215 Sept 2026
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletPsychiatryAmphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 5 mg; 5 mg; 5 mg; 5 mg (NDC 42806-344-01)CurrentLimited Availability12 Oct 202215 Sept 2026
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletPsychiatryAmphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg (NDC 42806-345-01)CurrentLimited Availability12 Oct 202215 Sept 2026
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletPsychiatryAmphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg (NDC 42806-341-01)CurrentLimited Availability12 Oct 202215 Sept 2026
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletPsychiatryAmphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg (NDC 42806-343-01)CurrentLimited Availability12 Oct 202215 Sept 2026
Rifampin CapsuleAnti-InfectiveRifampin, Capsule, 150 mg (NDC 42806-801-30)CurrentAvailable22 Dec 202115 Sept 2026
Rifampin CapsuleAnti-InfectiveRifampin, Capsule, 150 mg (NDC 42806-801-01)CurrentUnavailable22 Dec 202115 Sept 2026
Rifampin CapsuleAnti-InfectiveRifampin, Capsule, 300 mg (NDC 42806-799-30)CurrentUnavailable22 Dec 202115 Sept 2026
Rifampin CapsuleAnti-InfectiveRifampin, Capsule, 300 mg (NDC 42806-799-01)CurrentUnavailable22 Dec 202115 Sept 2026
Rifampin CapsuleAnti-InfectiveRifampin, Capsule, 300 mg (NDC 42806-799-05)CurrentUnavailable22 Dec 202115 Sept 2026
Rifampin CapsuleAnti-InfectiveRifampin, Capsule, 300 mg (NDC 42806-799-60)CurrentAvailable22 Dec 202115 Sept 2026
Catalogue

Drug listings by form and route

209

209 active NDC listings: 196 human prescription drug, 13 human otc drug. By marketing category: ANDA 196, OTC MONOGRAPH DRUG 10, OTC MONOGRAPH FINAL 2, UNAPPROVED DRUG OTHER 1.

Dosage formNDCs
tablet76
capsule38
tablet, film coated24
tablet, extended release19
powder, for suspension12
capsule, gelatin coated5
capsule, liquid filled5
tablet, film coated, extended release5
capsule, extended release3
granule3
injection, powder, for solution3
liquid3
lotion3
powder3
solution2
RouteNDCs
oral195
topical13
intravenous3
respiratory (inhalation)1
Labeller name on the listingNDCs
epic pharma, llc124
epic pharma, llc47
epic pharma llc18
epic pharma llc9
epic laboratories, llc4
epic medical supply corp.4
epic medical supply corp3
Catalogue

Marketed products

209

Showing 150 of 209.

BrandGeneric nameForm / routeNDC
2000DL-CL30TSPF30 BS Tropicallotion, topical58418-004OTC MONOGRAPH DRUG
2000DL-CL30VSPF30 BS originallotion, topical58418-000OTC MONOGRAPH DRUG
2000DL-CL30VSPF30 BS vanillalotion, topical58418-003OTC MONOGRAPH DRUG
AMLODIPINE BESYLATEAMLODIPINE BESYLATEtablet, oral42806-055ANDA
AMLODIPINE BESYLATEAMLODIPINE BESYLATEtablet, oral42806-056ANDA
AMLODIPINE BESYLATEAMLODIPINE BESYLATEtablet, oral42806-057ANDA
AZITHROMYCINazithromycinpowder, for suspension, oral42806-147ANDA
AZITHROMYCINazithromycinpowder, for suspension, oral42806-149ANDA
AZITHROMYCINazithromycinpowder, for suspension, oral42806-150ANDA
AZITHROMYCINazithromycinpowder, for suspension, oral42806-151ANDA
Amphetamine SulfateAmphetamine Sulfatetablet, oral42806-029ANDA
Amphetamine SulfateAmphetamine Sulfatetablet, oral42806-030ANDA
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEtablet, extended release, oral42806-410ANDA
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEtablet, extended release, oral42806-411ANDA
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEtablet, extended release, oral42806-415ANDA
BenzonatateBenzonatatecapsule, oral42806-714ANDA
BenzonatateBenzonatatecapsule, oral42806-715ANDA
Benzphetamine HydrochlorideBenzphetamine Hydrochloridetablet, film coated, oral42806-081ANDA
BetaxololBetaxololtablet, film coated, oral42806-038ANDA
BetaxololBetaxololtablet, film coated, oral42806-039ANDA
Bupropion Hydrochloride SRbupropion hydrochloridetablet, film coated, extended release, oral42806-413ANDA
Bupropion Hydrochloride SRbupropion hydrochloridetablet, extended release, oral42806-424ANDA
Bupropion Hydrochloride SRbupropion hydrochloridetablet, extended release, oral42806-425ANDA
Bupropion Hydrochloride SRbupropion hydrochloridetablet, extended release, oral42806-426ANDA
Bupropion Hydrochloride XLBupropion Hydrochloridetablet, extended release, oral42806-348ANDA
Bupropion Hydrochloride XLBupropion Hydrochloridetablet, extended release, oral42806-349ANDA
Bupropion Hydrochloride XLbupropion hydrochloridetablet, extended release, oral42806-414ANDA
Bupropion Hydrochloride XLbupropion hydrochloridetablet, extended release, oral42806-416ANDA
Buspirone HydrochlorideBuspirone Hydrochloridetablet, oral42806-082ANDA
Buspirone HydrochlorideBuspirone Hydrochloridetablet, oral42806-083ANDA
Buspirone HydrochlorideBuspirone Hydrochloridetablet, oral42806-084ANDA
Buspirone HydrochlorideBuspirone Hydrochloridetablet, oral42806-085ANDA
Buspirone HydrochlorideBuspirone Hydrochloridetablet, oral42806-086ANDA
Buspirone HydrochlorideBuspirone Hydrochloridecapsule, oral42806-831ANDA
Buspirone HydrochlorideBuspirone Hydrochloridecapsule, oral42806-832ANDA
Buspirone HydrochlorideBuspirone Hydrochloridecapsule, oral42806-833ANDA
Buspirone hydrochlorideBuspirone hydrochloridetablet, oral42806-662ANDA
Buspirone hydrochlorideBuspirone hydrochloridetablet, oral42806-663ANDA
Buspirone hydrochlorideBuspirone hydrochloridetablet, oral42806-664ANDA
Buspirone hydrochlorideBuspirone hydrochloridetablet, oral42806-665ANDA
CALCITRIOLCALCITRIOLcapsule, oral42806-732ANDA
CALCITRIOLCALCITRIOLcapsule, oral42806-733ANDA
CHLORDIAZEPOXIDE HYDROCHLORIDECHLORDIAZEPOXIDE HYDROCHLORIDEcapsule, gelatin coated, oral42806-562ANDA
CHLORDIAZEPOXIDE HYDROCHLORIDECHLORDIAZEPOXIDE HYDROCHLORIDEcapsule, gelatin coated, oral42806-563ANDA
CHLORDIAZEPOXIDE HYDROCHLORIDECHLORDIAZEPOXIDE HYDROCHLORIDEcapsule, gelatin coated, oral42806-564ANDA
CHLORDIAZEPOXIDE HYDROCHLORIDECHLORDIAZEPOXIDE HYDROCHLORIDEcapsule, gelatin coated, oral42806-565ANDA
CHLORDIAZEPOXIDE HYDROCHLORIDECHLORDIAZEPOXIDE HYDROCHLORIDEcapsule, gelatin coated, oral42806-566ANDA
CHOLESTYRAMINEcholestyraminepowder, for suspension, oral42806-265ANDA
CHOLESTYRAMINEcholestyraminepowder, for suspension, oral42806-266ANDA
CHOLESTYRAMINEcholestyraminepowder, for suspension, oral42806-267ANDA
CHOLESTYRAMINE LIGHTcholestyramine lightpowder, for suspension, oral42806-269ANDA
CHOLESTYRAMINE LIGHTcholestyramine lightpowder, for suspension, oral42806-270ANDA
CHOLESTYRAMINE LIGHTcholestyramine lightpowder, for suspension, oral42806-271ANDA
CITALOPRAMcitalopramtablet, film coated, oral42806-019ANDA
CITALOPRAMcitalopramtablet, film coated, oral42806-020ANDA
CITALOPRAMcitalopramtablet, film coated, oral42806-021ANDA
Carbamazepine ERCarbamazepinetablet, extended release, oral42806-274ANDA
Carbamazepine ERCarbamazepinetablet, extended release, oral42806-275ANDA
Carbamazepine ERCarbamazepinetablet, extended release, oral42806-276ANDA
CelecoxibCelecoxibcapsule, oral42806-720ANDA
CelecoxibCelecoxibcapsule, oral42806-721ANDA
CelecoxibCelecoxibcapsule, oral42806-722ANDA
CelecoxibCelecoxibcapsule, oral42806-723ANDA
Cyclophosphamidecyclophosphamideinjection, powder, for solution, intravenous, oral42806-901ANDA
Cyclophosphamidecyclophosphamideinjection, powder, for solution, intravenous, oral42806-902ANDA
Cyclophosphamidecyclophosphamideinjection, powder, for solution, intravenous, oral42806-903ANDA
Deferasirox Oral Granulesdeferasiroxgranule, oral42806-371ANDA
Deferasirox Oral Granulesdeferasiroxgranule, oral42806-372ANDA
Deferasirox Oral Granulesdeferasiroxgranule, oral42806-373ANDA
Demeclocycline HydrochlorideDemeclocycline Hydrochloridetablet, film coated, oral42806-143ANDA
Demeclocycline HydrochlorideDemeclocycline Hydrochloridetablet, film coated, oral42806-144ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfatetablet, oral42806-339ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfatetablet, oral42806-341ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfatetablet, oral42806-343ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfatetablet, oral42806-344ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfatetablet, oral42806-345ANDA
Diphenhydramine HydrochlorideDiphenhydramine Hydrochloridecapsule, oral42806-648OTC MONOGRAPH FINAL
Diphenhydramine HydrochlorideDiphenhydramine Hydrochloridecapsule, oral42806-649OTC MONOGRAPH FINAL
Doxepin HydrochlorideDoxepin Hydrochloridecapsule, oral42806-529ANDA
Doxepin HydrochlorideDoxepin Hydrochloridecapsule, oral42806-530ANDA
Doxepin HydrochlorideDoxepin Hydrochloridecapsule, oral42806-531ANDA
Doxepin HydrochlorideDoxepin Hydrochloridecapsule, oral42806-532ANDA
Doxepin HydrochlorideDoxepin Hydrochloridecapsule, oral42806-533ANDA
Doxycycline HyclateDoxycycline Hyclatetablet, film coated, oral42806-310ANDA
Doxycycline HyclateDoxycycline Hyclatetablet, oral42806-362ANDA
DutasterideDutasteridecapsule, liquid filled, oral42806-549ANDA
ESTRADIOLESTRADIOLtablet, oral42806-087ANDA
ESTRADIOLESTRADIOLtablet, oral42806-088ANDA
ESTRADIOLESTRADIOLtablet, oral42806-089ANDA
ETHAMBUTOL HYDROCHLORIDEETHAMBUTOL HYDROCHLORIDEtablet, film coated, oral42806-101ANDA
ETHAMBUTOL HYDROCHLORIDEETHAMBUTOL HYDROCHLORIDEtablet, film coated, oral42806-102ANDA
EntecavirEntecavirtablet, oral42806-658ANDA
EntecavirEntecavirtablet, oral42806-659ANDA
Entecavirentecavirtablet, film coated, oral42806-667ANDA
Entecavirentecavirtablet, film coated, oral42806-668ANDA
Ergocalciferol Capsules,Ergocalciferol Capsules,capsule, oral42806-547ANDA
EthosuximideEthosuximidecapsule, oral42806-708ANDA
EthosuximideEthosuximidecapsule, oral42806-711ANDA
FIRST AID BURNLIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDEcream, topical82749-009OTC MONOGRAPH DRUG
Flavoxate HydrochlorideFlavoxate Hydrochloridetablet, oral42806-058ANDA
Flecainide Acetateflecainide acetatetablet, oral42806-817ANDA
Flecainide Acetateflecainide acetatetablet, oral42806-818ANDA
Flecainide Acetateflecainide acetatetablet, oral42806-819ANDA
GabapentinGabapentincapsule, oral42806-509ANDA
GabapentinGabapentincapsule, oral42806-510ANDA
GabapentinGabapentincapsule, oral42806-511ANDA
GabapentinGabapentintablet, oral42806-656ANDA
GabapentinGabapentintablet, oral42806-657ANDA
GuanfacineGuanfacinetablet, oral42806-048ANDA
GuanfacineGuanfacinetablet, oral42806-296ANDA
Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophentablet, oral42806-111ANDA
Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophentablet, oral42806-112ANDA
Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophentablet, oral42806-113ANDA
Hydrogen Peroxide 3%Hydrogen Peroxide 3%solution, topical82749-001OTC MONOGRAPH DRUG
Hydroxyzine HydrochlorideHydroxyzine Hydrochloridetablet, film coated, oral42806-159ANDA
Hydroxyzine HydrochlorideHydroxyzine Hydrochloridetablet, film coated, oral42806-160ANDA
Hydroxyzine HydrochlorideHydroxyzine Hydrochloridetablet, film coated, oral42806-161ANDA
ICOSAPENT ETHYLicosapent ethylcapsule, liquid filled, oral42806-559ANDA
ICOSAPENT ETHYLicosapent ethylcapsule, liquid filled, oral42806-560ANDA
ICOSAPENT ETHYLicosapent ethylcapsule, liquid filled, oral42806-576ANDA
Isopropyl AlcoholIsopropyl Alcoholliquid, topical82749-004OTC MONOGRAPH DRUG
Isopropyl Rubbing AlcoholIsopropyl Alcoholsolution, topical82749-002OTC MONOGRAPH DRUG
KLAYESTANystatin Topical Powderpowder, topical42806-186ANDA
Labetalol HydrochlorideLabetalol Hydrochloridetablet, oral42806-327ANDA
Labetalol HydrochlorideLabetalol Hydrochloridetablet, oral42806-328ANDA
Labetalol HydrochlorideLabetalol Hydrochloridetablet, oral42806-329ANDA
Leucovorin CalciumLeucovorin Calciumtablet, oral42806-133ANDA
Leucovorin CalciumLeucovorin Calciumtablet, oral42806-134ANDA
Leucovorin CalciumLeucovorin Calciumtablet, oral42806-358ANDA
Leucovorin CalciumLeucovorin Calciumtablet, oral42806-359ANDA
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEtablet, extended release, oral42806-632ANDA
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEtablet, extended release, oral42806-633ANDA
METHYLPREDNISOLONEMETHYLPREDNISOLONEtablet, oral42806-400ANDA
Meclizine HydrochlorideMeclizine Hydrochloridetablet, oral42806-012ANDA
Meclizine HydrochlorideMeclizine Hydrochloridetablet, oral42806-014ANDA
Meperidine HydrochlorideMeperidine Hydrochloridetablet, oral42806-050ANDA
Meperidine HydrochlorideMeperidine Hydrochloridetablet, oral42806-051ANDA
Metformin HydrochlorideMetformin Hydrochloridetablet, film coated, oral42806-313ANDA
Metformin HydrochlorideMetformin Hydrochloridetablet, film coated, oral42806-314ANDA
Metformin HydrochlorideMetformin Hydrochloridetablet, film coated, oral42806-315ANDA
Methadone HydrochlorideMethadone Hydrochloridetablet, oral42806-317ANDA
Methadone HydrochlorideMethadone Hydrochloridetablet, oral42806-318ANDA
Metoprolol succinateMetoprolol succinatetablet, extended release, oral42806-724ANDA
Metoprolol succinateMetoprolol succinatetablet, extended release, oral42806-725ANDA
Metoprolol succinateMetoprolol succinatetablet, extended release, oral42806-726ANDA
Metoprolol succinateMetoprolol succinatetablet, extended release, oral42806-727ANDA
Molindone HydrochlorideMolindone Hydrochloridetablet, oral42806-336ANDA
Molindone HydrochlorideMolindone Hydrochloridetablet, oral42806-337ANDA
Molindone HydrochlorideMolindone Hydrochloridetablet, oral42806-338ANDA
Nicardipine HydrochlorideNicardipine Hydrochloridecapsule, oral42806-501ANDA
Neighbours

Registered in the same town

10
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Enquiry

Common questions

Is Epic Laboratories, LLC FDA approved?
Epic Laboratories, LLC holds 3 FDA-registered establishments in the United States. 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 Epic Laboratories, LLC's drugs manufactured?
The FDA register lists Laurelton, NY; Tampa, FL; Westbury, NY. Registered operations: labelling, finished drug manufacture, packaging.
What drugs does Epic Laboratories, LLC make?
209 products are listed under Epic Laboratories, LLC in the openFDA NDC Directory, most often as tablet; capsule; tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Are any Epic Laboratories, LLC products in shortage?
11 presentations are currently listed in the FDA drug shortage database under Epic Laboratories, LLC, covering Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet, Rifampin Capsule.

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.