Medical emergency?Emergency? Call 911. Nearest emergency roomsNearest ERs

Español Near me My list Help
US Patient GuideUSA
Surprise me
Drug company (FDA labeler)

ANI Pharmaceuticals, Inc.

NDC labeler codes: 43975, 62559, 68611, 70954

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

123Prescription medicines
291Products (NDC)
143FDA applications
6Recalls

Prescription medicines

Show the other 83 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
September 21, 2026ANDA220597 Everolimus
EVEROLIMUS		Novitium Pharma
August 12, 2026ANDA210426 Fosfomycin
FOSFOMYCIN TROMETHAMINE		Novitium Pharma
June 29, 2026ANDA219918 Rifampin
RIFAMPIN		Novitium Pharma
April 13, 2026ANDA219897 Pimozide
PIMOZIDE		Novitium Pharma
April 6, 2026ANDA211156 Dapagliflozin
DAPAGLIFLOZIN		Inventia
February 2, 2026ANDA219919 Mirtazapine
MIRTAZAPINE		Novitium Pharma
January 26, 2026ANDA219119 Tapentadol hydrochloride
TAPENTADOL HYDROCHLORIDE		Novitium Pharma
January 20, 2026ANDA219714 Sertraline hydrochloride
SERTRALINE HYDROCHLORIDE		Novitium Pharma
December 16, 2025ANDA219648 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE		Novitium Pharma
December 10, 2025ANDA219161 Omeprazole and sodium bicarbonate
OMEPRAZOLE AND SODIUM BICARBONATE		Novitium Pharma
November 5, 2025ANDA211120 Macitentan
MACITENTAN		Laurus
October 22, 2025ANDA219917 Lofexidine hydrochloride
LOFEXIDINE HYDROCHLORIDE		Novitium Pharma
October 17, 2025ANDA219781 Clomiphene citrate
CLOMIPHENE CITRATE		Novitium Pharma
May 2, 2025ANDA217881 Hydrocortisone
HYDROCORTISONE		Novitium Pharma
April 16, 2025ANDA215269 Mesalamine
MESALAMINE		Novitium Pharma
February 3, 2025ANDA214844 Nitazoxanide
NITAZOXANIDE		Ani Pharms
January 28, 2025NDA219141 Hydrochlorothiazide
INZIRQO		Novitium Pharma
January 7, 2025ANDA219118 Nabumetone
NABUMETONE		Novitium Pharma
December 26, 2024ANDA218492 Prucalopride
PRUCALOPRIDE SUCCINATE		Novitium Pharma
October 23, 2024ANDA217882 Estradiol
ESTRADIOL		Novitium Pharma
September 16, 2024ANDA218498 Ketoconazole
KETOCONAZOLE		Novitium Pharma
July 29, 2024NDA218139 Terazosin hydrochloride
TEZRULY		Novitium Pharma
July 8, 2024ANDA215647 L-glutamine
L-GLUTAMINE		Novitium Pharma
June 12, 2024ANDA218497 Naproxen
NAPROXEN		Novitium Pharma
May 28, 2024ANDA213676 Sacubitril and valsartan
SACUBITRIL AND VALSARTAN		Laurus
Show the other 100 applications
ApprovedApplicationMedicineSponsor
January 25, 2024ANDA215901 Carboprost tromethamine
CARBOPROST TROMETHAMINE		Ani Pharms
January 12, 2024ANDA217883 Indomethacin
INDOMETHACIN		Novitium Pharma
December 15, 2023ANDA208237 Memantine and donepezil
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE		Ani Pharms
September 6, 2023ANDA217334 Estradiol
ESTRADIOL		Novitium Pharma
August 29, 2023ANDA216383 Sildenafil
SILDENAFIL CITRATE		Novitium Pharma
August 24, 2023ANDA217610 Estradiol
ESTRADIOL		Novitium Pharma
July 12, 2023ANDA212816 Potassium chloride
POTASSIUM CHLORIDE		Novitium Pharma
June 8, 2023ANDA217252 Baclofen
BACLOFEN		Ani Pharms
May 11, 2023ANDA214512 Alendronate sodium
ALENDRONATE SODIUM		Novitium Pharma
May 9, 2023ANDA217696 Dexamethasone
DEXAMETHASONE		Novitium Pharma
May 1, 2023ANDA217213 Methsuximide
METHSUXIMIDE		Novitium Pharma
April 14, 2023ANDA216385 Nitrofurantoin
NITROFURANTOIN		Novitium Pharma
March 10, 2023ANDA216517 Colestipol hydrochloride
COLESTIPOL HYDROCHLORIDE		Ani Pharms
March 3, 2023ANDA215949 Tadalafil
TADALAFIL		Novitium Pharma
December 9, 2022ANDA216384 Levocarnitine
LEVOCARNITINE		Novitium Pharma
November 9, 2022ANDA216448 Fluoxetine
FLUOXETINE HYDROCHLORIDE		Novitium Pharma
October 6, 2022ANDA214277 Carbamazepine
CARBAMAZEPINE		Novitium Pharma
August 26, 2022ANDA216151 Lacosamide
LACOSAMIDE		Novitium Pharma
August 8, 2022ANDA215604 Dexamethasone
DEXAMETHASONE		Novitium Pharma
July 19, 2022ANDA212722 Pirfenidone
PIRFENIDONE		Laurus
June 16, 2022ANDA213730 Clorazepate dipotassium
CLORAZEPATE DIPOTASSIUM		Novitium Pharma
June 13, 2022ANDA216202 Prochlorperazine
PROCHLORPERAZINE MALEATE		Novitium Pharma
February 18, 2022ANDA215270 Methyltestosterone
METHYLTESTOSTERONE		Novitium Pharma
February 8, 2022ANDA214330 Sulfamethoxazole and trimethoprim
SULFAMETHOXAZOLE AND TRIMETHOPRIM		Novitium Pharma
January 14, 2022NDA214581 Hydroxychloroquine sulfate
SOVUNA		Novitium Pharma
December 17, 2021ANDA215041 Rifabutin
RIFABUTIN		Novitium Pharma
November 22, 2021ANDA215307 Digoxin
DIGOXIN		Novitium Pharma
November 4, 2021ANDA215562 Bisoprolol fumarate and hydrochlorothiazide
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE		Novitium Pharma
November 2, 2021ANDA214102 Valsartan
VALSARTAN		Novitium Pharma
October 25, 2021ANDA215560 Atenolol and chlorthalidone
ATENOLOL AND CHLORTHALIDONE		Novitium Pharma
September 3, 2021ANDA215003 Paroxetine
PAROXETINE HYDROCHLORIDE		Novitium Pharma
July 6, 2021ANDA215246 Prednisone
PREDNISONE		Novitium Pharma
April 20, 2021ANDA215043 Famotidine
FAMOTIDINE		Novitium Pharma
March 10, 2021ANDA211910 Naproxen
NAPROXEN		Novitium Pharma
March 9, 2021ANDA211398 Meloxicam
MELOXICAM		Novitium Pharma
March 1, 2021ANDA214674 Fluphenazine hydrochloride
FLUPHENAZINE HYDROCHLORIDE		Novitium Pharma
July 10, 2020ANDA212252 Acyclovir
ACYCLOVIR		Novitium Pharma
January 14, 2020ANDA212779 Potassium citrate
POTASSIUM CITRATE		Ani Pharms
November 15, 2019ANDA211575 Prednisone
PREDNISONE		Novitium Pharma
October 17, 2019ANDA210588 Acetazolamide
ACETAZOLAMIDE		Novitium Pharma
August 19, 2019ANDA204562 Tolterodine tartrate
TOLTERODINE TARTRATE		Inventia Hlthcare
August 14, 2019ANDA211676 Levocarnitine
LEVOCARNITINE, LEVOCARNITINE SF		Novitium Pharma
June 12, 2019ANDA204452 Paliperidone
PALIPERIDONE		Adaptis
May 31, 2019ANDA212260 Sildenafil
SILDENAFIL CITRATE		Novitium Pharma
April 5, 2019ANDA211642 Thiothixene
THIOTHIXENE		Novitium Pharma
January 22, 2019ANDA205401 Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE		Ani Pharms
October 12, 2018NDA210331 Fluocinolone acetonide
YUTIQ		Alimera Sciences Inc
October 3, 2018ANDA210971 Prazosin hydrochloride
PRAZOSIN HYDROCHLORIDE		Novitium Pharma
May 8, 2018ANDA209861 Bexarotene
BEXAROTENE		Ani Pharms
April 30, 2018ANDA209504 Fenofibrate
FENOFIBRATE (MICRONIZED)		Ani Pharms
April 17, 2018ANDA208342 Miglustat
MIGLUSTAT		Ani Pharms
October 23, 2017ANDA209823 Oxybutynin
OXYBUTYNIN CHLORIDE		Novitium Pharma
December 1, 2016ANDA206505 Dapsone
DAPSONE		Novitium Pharma
July 25, 2016ANDA203256 Tranexamic acid
TRANEXAMIC ACID		Ani Pharms
July 15, 2016ANDA207631 Nilutamide
NILUTAMIDE		Ani Pharms
March 31, 2016ANDA205177 Oxycodone hydrochloride
OXYCODONE HYDROCHLORIDE		Ani Pharms
November 4, 2015ANDA202284 Felbamate
FELBAMATE		Ani Pharms
October 28, 2015ANDA202336 Duloxetine
DULOXETINE HYDROCHLORIDE		Inventia
June 1, 2015ANDA204979 Oxycodone hydrochloride
OXYCODONE HYDROCHLORIDE		Ani Pharms
April 16, 2015ANDA203659 Nebivolol
NEBIVOLOL HYDROCHLORIDE		Ani Pharms
September 26, 2014NDA201923 Fluocinolone acetonide
ILUVIEN		Alimera Sciences Inc
June 20, 2011ANDA091678 Levofloxacin
LEVOFLOXACIN		Novitium Pharma
May 20, 2011ANDA076697 Carbamazepine
CARBAMAZEPINE		Ani Pharms
March 7, 2011ANDA078423 Fluconazole
FLUCONAZOLE		Ani Pharms
January 30, 2009ANDA076440 Risperidone
RISPERIDONE		Ani Pharms
December 20, 2007NDA021519 Fluvoxamine maleate
LUVOX		Ani Pharms
December 11, 2007ANDA078005 Oxcarbazepine
OXCARBAZEPINE		Ani Pharms
September 17, 2007ANDA040028 Sodium polystyrene sulfonate
KIONEX		Ani Pharms
December 13, 2006ANDA077396 Lorazepam
LORAZEPAM		Ani Pharms
October 31, 2006NDA021902 Sinecatechins
VEREGEN		Ani Pharms
February 16, 2006ANDA077404 Megestrol acetate
MEGESTROL ACETATE		Novitium Pharma
January 11, 2006NDA021612 Fenofibrate
LIPOFEN		Cipher Pharms Inc
April 18, 2005ANDA076811 Anagrelide
ANAGRELIDE HYDROCHLORIDE		Novitium Pharma
April 23, 2004ANDA076550 Propafenone hydrochloride
PROPAFENONE HYDROCHLORIDE		Ani Pharms
February 11, 2004ANDA076333 Benazepril hydrochloride
BENAZEPRIL HYDROCHLORIDE		Ani Pharms
February 11, 2004ANDA076342 Benazepril hydrochloride and hydrochlorothiazide
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE		Ani Pharms
October 8, 2003ANDA040512 Pyridostigmine bromide
PYRIDOSTIGMINE BROMIDE		Ani Pharms
March 12, 2003NDA021438 Propranolol hydrochloride
INNOPRAN XL		Ani Pharms
October 28, 2002ANDA075882 Flecainide acetate
FLECAINIDE ACETATE		Ani Pharms
July 10, 2002ANDA076095 Misoprostol
MISOPROSTOL		Ani Pharms
September 5, 2000NDA021093 Candesartan cilexetil and hydrochlorothiazide
ATACAND HCT		Ani Pharms
September 16, 1999ANDA075126 Etodolac
ETODOLAC		Ani Pharms
November 27, 1998ANDA075147 Isosorbide mononitrate
ISOSORBIDE MONONITRATE		Ani Pharms
November 20, 1998NDA021068 Calcitriol
ROCALTROL		Esjay Pharma
June 4, 1998NDA020838 Candesartan cilexetil
ATACAND		Ani Pharms
July 9, 1997ANDA074878 Pentoxifylline
PENTOXIFYLLINE		Ani Pharms
October 28, 1996ANDA074670 Nicardipine
NICARDIPINE HYDROCHLORIDE		Ani Pharms
May 16, 1996ANDA074450 Mexiletine hydrochloride
MEXILETINE HYDROCHLORIDE		Ani Pharms
December 27, 1995NDA020541 Anastrozole
ARIMIDEX		Ani Pharms
October 18, 1995ANDA074007 Acebutolol hydrochloride
ACEBUTOLOL HYDROCHLORIDE		Ani Pharms
October 4, 1995NDA020498 Bicalutamide
CASODEX		Ani Pharms
August 31, 1995ANDA074497 Glipizide
GLIPIZIDE		Ani Pharms
July 27, 1995ANDA074299 Indapamide
INDAPAMIDE		Ani Pharms
October 19, 1993ANDA074174 Alprazolam
ALPRAZOLAM		Novitium Pharma
June 30, 1993ANDA040001 Methazolamide
METHAZOLAMIDE		Ani Pharms
June 25, 1993ANDA071402 Metoclopramide
METOCLOPRAMIDE HYDROCHLORIDE		Ani Pharms
March 29, 1993ANDA073609 Pindolol
PINDOLOL		Ani Pharms
September 30, 1992NDA020209 Oxiconazole nitrate
OXISTAT		Ani Pharms
August 25, 1992ANDA073178 Valproic acid
VALPROIC ACID		Ani Pharms
December 24, 1987NDA019618 Mesalamine
ROWASA, SFROWASA		Mylan Speciality LP

Showing the 125 newest of 143 applications. Full lists: Drugs@FDA →

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

Recall timeline

2020

  1. October 9, 2020 · Class III · Terminated · D-0044-2021 · Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

    Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 10 mg, 100-count bottle,

  2. October 9, 2020 · Class III · Terminated · D-0047-2021 · Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

    Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 25 mg, 100-count bottle,

  3. October 9, 2020 · Class III · Terminated · D-0046-2021 · Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

    Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 20 mg, 100-count bottle,

  4. October 9, 2020 · Class III · Terminated · D-0045-2021 · Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

    Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 15 mg, 100-count bottle,

  5. October 9, 2020 · Class III · Terminated · D-0043-2021 · Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

    Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 5 mg, 100-count bottle, R

  6. October 9, 2020 · Class III · Terminated · D-0048-2021 · Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

    Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 30 mg, 100-count bottle,

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

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 →