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Drug company (FDA labeler)

Alembic Pharmaceuticals Limited

NDC labeler code: 46708

What is a labeler?

The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.

Official FDA data only

Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.

Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.

At a glance

152Prescription medicines
479Products (NDC)
201FDA applications
0Recalls

Prescription medicines

Show the other 112 medicines

FDA applications for these products

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
ApprovedApplicationMedicineSponsor
October 15, 2026ANDA217723 Ciprofloxacin and dexamethasone
CIPROFLOXACIN AND DEXAMETHASONE		Alembic
July 27, 2026ANDA219234 Prucalopride
PRUCALOPRIDE SUCCINATE		Alembic
June 25, 2026ANDA213414 Dapsone
DAPSONE		Alembic
June 25, 2026ANDA218307 Oseltamivir phosphate
OSELTAMIVIR PHOSPHATE		Alembic
June 11, 2026ANDA214590 Tretinoin
TRETINOIN		Alembic
April 24, 2026ANDA207974 Fingolimod
FINGOLIMOD HYDROCHLORIDE		Alembic
April 15, 2026ANDA220225 Methotrexate
METHOTREXATE SODIUM		Alembic
April 6, 2026ANDA211560 Dapagliflozin
DAPAGLIFLOZIN		Alembic
February 25, 2026ANDA217278 Lamotrigine
LAMOTRIGINE		Alembic
February 5, 2026ANDA218535 Carbidopa, levodopa and entacapone
CARBIDOPA, LEVODOPA AND ENTACAPONE		Alembic
January 26, 2026ANDA213774 Difluprednate
DIFLUPREDNATE		Alembic
December 17, 2025ANDA214687 Travoprost ophthalmic solution
TRAVOPROST		Alembic
December 10, 2025ANDA217597 Loteprednol etabonate and tobramycin
LOTEPREDNOL ETABONATE AND TOBRAMYCIN		Alembic
November 14, 2025ANDA217633 Diltiazem
DILTIAZEM HYDROCHLORIDE		Alembic
November 12, 2025ANDA219115 Dexlansoprazole
DEXLANSOPRAZOLE		Alembic
November 6, 2025ANDA213518 Sumatriptan
SUMATRIPTAN SUCCINATE (AUTOINJECTOR)		Alembic
November 6, 2025ANDA216261 Dasatinib
DASATINIB		Alembic
October 17, 2025ANDA218601 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE		Alembic
September 24, 2025ANDA217280 Paroxetine
PAROXETINE HYDROCHLORIDE		Alembic
September 8, 2025ANDA216444 Phytonadione
PHYTONADIONE		Alembic
August 18, 2025ANDA211128 Macitentan
MACITENTAN		Alembic
August 14, 2025ANDA218399 Tretinoin
TRETINOIN		Alembic
July 25, 2025ANDA219939 Carbamazepine
CARBAMAZEPINE		Alembic
June 27, 2025ANDA219199 Doxorubicin hydrochloride
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)		Alembic
May 23, 2025ANDA209543 Bosutinib
BOSUTINIB MONOHYDRATE		Alembic
Show the other 100 applications
ApprovedApplicationMedicineSponsor
May 22, 2025ANDA217279 Amlodipine and atorvastatin
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM		Alembic
May 14, 2025ANDA210301 Rivaroxaban
RIVAROXABAN		Alembic
May 2, 2025ANDA208576 Ticagrelor
TICAGRELOR		Alembic
April 16, 2025ANDA216623 Carbamazepine
CARBAMAZEPINE		Alembic
March 31, 2025ANDA219230 Pantoprazole sodium
PANTOPRAZOLE SODIUM		Alembic
December 19, 2024ANDA218793 Divalproex sodium
DIVALPROEX SODIUM		Alembic
November 8, 2024ANDA215238 Ivabradine
IVABRADINE HYDROCHLORIDE		Alembic
November 8, 2024ANDA216968 Diltiazem
DILTIAZEM HYDROCHLORIDE		Alembic
October 18, 2024ANDA218587 Diltiazem
DILTIAZEM HYDROCHLORIDE		Alembic
October 1, 2024ANDA211821 Lamotrigine
LAMOTRIGINE		Alembic
September 26, 2024ANDA218330 Paliperidone
PALIPERIDONE		Alembic
September 4, 2024ANDA215652 Albendazole
ALBENDAZOLE		Alembic
August 22, 2024ANDA215832 Betamethasone valerate
BETAMETHASONE VALERATE		Alembic
August 5, 2024ANDA217774 Acitretin
ACITRETIN		Alembic
August 1, 2024ANDA218554 Nelarabine
NELARABINE		Alembic
July 23, 2024ANDA218173 Fluphenazine hydrochloride
FLUPHENAZINE HYDROCHLORIDE		Alembic
July 8, 2024ANDA214340 Bromfenac
BROMFENAC SODIUM		Alembic
June 27, 2024ANDA217674 Doxycycline
DOXYCYCLINE		Alembic
June 14, 2024ANDA213773 Icatibant
ICATIBANT ACETATE		Alembic
June 14, 2024ANDA215233 Dabigatran etexilate
DABIGATRAN ETEXILATE MESYLATE		Alembic
June 6, 2024ANDA217767 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE		Alembic
June 3, 2024ANDA217552 Methotrexate
METHOTREXATE SODIUM		Alembic
May 28, 2024ANDA213682 Sacubitril and valsartan
SACUBITRIL AND VALSARTAN		Alembic
April 29, 2024ANDA217804 Tretinoin
TRETINOIN		Alembic
April 25, 2024ANDA218450 Diazepam
DIAZEPAM		Alembic
April 2, 2024ANDA212466 Clindamycin
CLINDAMYCIN PHOSPHATE		Alembic
October 27, 2023ANDA215718 Dapsone
DAPSONE		Alembic
October 18, 2023ANDA217676 Fluorouracil
FLUOROURACIL		Alembic
September 15, 2023ANDA216969 Chlordiazepoxide hydrochloride and clidinium bromide
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE		Alembic
August 25, 2023ANDA215230 Brimonidine tartrate and timolol maleate
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE		Alembic
August 24, 2023ANDA215661 Erythromycin
ERYTHROMYCIN		Alembic
August 7, 2023ANDA217269 Guanfacine
GUANFACINE HYDROCHLORIDE		Alembic
August 1, 2023ANDA216909 Brimonidine tartrate
BRIMONIDINE TARTRATE		Alembic
July 18, 2023ANDA217350 Chlorpromazine hydrochloride
CHLORPROMAZINE HYDROCHLORIDE		Alembic
June 15, 2023ANDA217198 Carboprost tromethamine
CARBOPROST TROMETHAMINE		Alembic
June 2, 2023ANDA211763 Nadolol
NADOLOL		Alembic
April 5, 2023ANDA214588 Bepotastine
BEPOTASTINE BESILATE		Alembic
March 29, 2023ANDA215225 Brimonidine tartrate
BRIMONIDINE TARTRATE		Alembic
March 6, 2023ANDA217268 Prazosin hydrochloride
PRAZOSIN HYDROCHLORIDE		Alembic
March 3, 2023ANDA217295 Fluorouracil
FLUOROURACIL		Alembic
February 28, 2023ANDA215744 Docetaxel
DOCETAXEL		Alembic
January 4, 2023ANDA204973 Fesoterodine fumarate
FESOTERODINE FUMARATE		Alembic
December 8, 2022ANDA214396 Desonide
DESONIDE		Alembic
November 29, 2022ANDA212506 Diclofenac
DICLOFENAC SODIUM		Alembic
November 18, 2022ANDA216896 Nifedipine
NIFEDIPINE		Alembic
November 10, 2022ANDA215892 Cyclophosphamide
CYCLOPHOSPHAMIDE		Alembic
October 28, 2022ANDA216967 Mesalamine
MESALAMINE		Alembic
October 20, 2022ANDA216874 Paclitaxel
PACLITAXEL		Alembic
August 26, 2022ANDA216262 Chlorthalidone
CHLORTHALIDONE		Alembic
August 4, 2022ANDA214185 Adapalene and benzoyl peroxide
ADAPALENE AND BENZOYL PEROXIDE		Alembic
July 27, 2022ANDA212351 Diclofenac
DICLOFENAC SODIUM		Alembic
May 20, 2022ANDA212708 Pirfenidone
PIRFENIDONE		Alembic
April 21, 2022ANDA215838 Clobetasol propionate
CLOBETASOL PROPIONATE		Alembic
April 8, 2022ANDA213923 Lidocaine and prilocaine
LIDOCAINE AND PRILOCAINE		Alembic
March 17, 2022ANDA204974 Lacosamide
LACOSAMIDE		Alembic
January 31, 2022ANDA210459 Clarithromycin
CLARITHROMYCIN		Alembic
January 4, 2022ANDA212601 Entacapone
ENTACAPONE		Alembic
January 3, 2022ANDA213075 Doxycycline
DOXYCYCLINE HYCLATE		Alembic
November 16, 2021ANDA213053 Mupirocin
MUPIROCIN		Alembic
September 3, 2021ANDA212646 Metronidazole
METRONIDAZOLE		Alembic
August 4, 2021ANDA211822 Clomipramine hydrochloride
CLOMIPRAMINE HYDROCHLORIDE		Alembic
July 8, 2021ANDA214719 Erlotinib
ERLOTINIB HYDROCHLORIDE		Alembic
July 7, 2021ANDA209785 Desipramine hydrochloride
DESIPRAMINE HYDROCHLORIDE		Alembic
June 25, 2021ANDA211935 Nitrofurantoin
NITROFURANTOIN		Alembic
May 13, 2021ANDA213248 Lurasidone hydrochloride
LURASIDONE HYDROCHLORIDE		Alembic
May 4, 2021ANDA213099 Dorzolamide hydrochloride and timolol maleate
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE		Alembic
April 21, 2021ANDA215076 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE		Alembic
March 31, 2021ANDA214090 Nystatin and triamcinolone acetonide
NYSTATIN AND TRIAMCINOLONE ACETONIDE		Alembic
January 21, 2021ANDA214734 Midodrine hydrochloride
MIDODRINE HYDROCHLORIDE		Alembic
December 10, 2020ANDA206098 Asenapine
ASENAPINE MALEATE		Alembic
December 2, 2020ANDA213251 Metolazone
METOLAZONE		Alembic
October 22, 2020ANDA212942 Timolol
TIMOLOL MALEATE		Alembic
October 21, 2020ANDA212188 Tavaborole
TAVABOROLE		Alembic
October 19, 2020ANDA213842 Fenofibrate
FENOFIBRATE (MICRONIZED)		Alembic
October 15, 2020ANDA214284 Amantadine
AMANTADINE HYDROCHLORIDE		Alembic
August 24, 2020ANDA213632 Desonide
DESONIDE		Alembic
August 4, 2020ANDA214031 Vardenafil
VARDENAFIL HYDROCHLORIDE		Alembic
June 30, 2020ANDA211744 Doxycycline
DOXYCYCLINE HYCLATE		Alembic
June 18, 2020ANDA213508 Adapalene
ADAPALENE		Alembic
May 18, 2020ANDA213290 Clobetasol propionate
CLOBETASOL PROPIONATE		Alembic
May 14, 2020ANDA210536 Doxycycline
DOXYCYCLINE HYCLATE		Alembic
March 4, 2020ANDA210537 Doxycycline
DOXYCYCLINE HYCLATE		Alembic
January 28, 2020ANDA211791 Azithromycin
AZITHROMYCIN		Alembic
January 28, 2020ANDA211792 Azithromycin
AZITHROMYCIN		Alembic
January 27, 2020ANDA211793 Azithromycin
AZITHROMYCIN		Alembic
January 27, 2020ANDA213291 Clobetasol propionate
CLOBETASOL PROPIONATE		Alembic
January 21, 2020ANDA210515 Bimatoprost
BIMATOPROST		Alembic
January 17, 2020ANDA213252 Fenofibrate
FENOFIBRATE		Alembic
January 13, 2020ANDA213223 Tizanidine
TIZANIDINE HYDROCHLORIDE		Alembic
January 10, 2020ANDA208202 Vilazodone hydrochloride
VILAZODONE HYDROCHLORIDE		Alembic
November 22, 2019ANDA211731 Silodosin
SILODOSIN		Alembic
November 20, 2019ANDA210060 Deferasirox
DEFERASIROX		Alembic
November 20, 2019ANDA211824 Deferasirox
DEFERASIROX		Alembic
October 23, 2019ANDA212473 Desonide
DESONIDE		Alembic
October 21, 2019ANDA212881 Clobetasol propionate
CLOBETASOL PROPIONATE		Alembic
October 2, 2019ANDA211191 Clobetasol propionate
CLOBETASOL PROPIONATE		Alembic
August 9, 2019ANDA210476 Fenofibrate
FENOFIBRATE		Alembic
August 9, 2019ANDA212639 Dorzolamide hydrochloride
DORZOLAMIDE HYDROCHLORIDE		Alembic
July 19, 2019ANDA203459 Pregabalin
PREGABALIN		Alembic
July 1, 2019ANDA205421 Febuxostat
FEBUXOSTAT		Alembic

Showing the 125 newest of 201 applications. Full lists: Drugs@FDA →

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

No recall of these products (by NDC code) appears in the FDA enforcement reports.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

FDA Enforcement Report search → · Report an error →