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Drug company (FDA labeler)

Bionpharma Inc.

NDC labeler code: 69452

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

62Prescription medicines
124Products (NDC)
66FDA applications
4Recalls

Prescription medicines

FDA applications for these products

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
ApprovedApplicationMedicineSponsor
December 23, 2025ANDA220062 Glycopyrrolate
GLYCOPYRROLATE		Bionpharma
October 28, 2025ANDA216187 Ticagrelor
TICAGRELOR		Changzhou Pharm
October 2, 2025ANDA219152 Etravirine
ETRAVIRINE		Bionpharma
September 18, 2025ANDA219904 Acamprosate calcium
ACAMPROSATE CALCIUM		Bionpharma
April 28, 2025ANDA219289 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE		Bionpharma
April 14, 2025ANDA219151 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Bionpharma
November 7, 2024ANDA218220 Cimetidine
CIMETIDINE		Bionpharma
September 5, 2024ANDA213276 Ivabradine
IVABRADINE HYDROCHLORIDE		Bionpharma
June 24, 2024ANDA204135 Sodium sulfate, potassium sulfate, magnesium sulfate
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE		Bionpharma
February 16, 2024ANDA218221 Carbamazepine
CARBAMAZEPINE		Bionpharma
January 22, 2024ANDA217917 Fluvoxamine maleate
FLUVOXAMINE MALEATE		Bionpharma
November 8, 2023ANDA218290 Cevimeline hydrochloride
CEVIMELINE HYDROCHLORIDE		Bionpharma
September 25, 2023ANDA218149 Methimazole
METHIMAZOLE		Bionpharma
August 4, 2023ANDA217000 Doxylamine succinate and pyridoxine hydrochloride
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE		Bionpharma
August 4, 2023ANDA217916 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE		Bionpharma
May 3, 2023ANDA217555 Nicardipine
NICARDIPINE HYDROCHLORIDE		Bionpharma
April 26, 2023ANDA216300 Theophylline
THEOPHYLLINE		Bionpharma
April 26, 2023ANDA217538 Dexamethasone
DEXAMETHASONE		Bionpharma
April 19, 2023ANDA217001 Dexamethasone
DEXAMETHASONE		Bionpharma
April 4, 2023ANDA217478 Prochlorperazine
PROCHLORPERAZINE MALEATE		Bionpharma
February 23, 2023ANDA216759 Ketorolac tromethamine
KETOROLAC TROMETHAMINE		Bionpharma
November 4, 2022ANDA209652 Oxcarbazepine
OXCARBAZEPINE		Bionpharma
October 22, 2021ANDA215579 Loperamide hydrochloride
LOPERAMIDE HYDROCHLORIDE		Bionpharma
August 10, 2021ANDA212408 Enalapril maleate
ENALAPRIL MALEATE		Bionpharma
May 17, 2021ANDA209374 Sevelamer carbonate
SEVELAMER CARBONATE		Bionpharma
April 28, 2021ANDA213033 Droxidopa
DROXIDOPA		Bionpharma
March 30, 2021ANDA212918 Atovaquone
ATOVAQUONE		Bionpharma
September 30, 2020ANDA203997 Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE		Bionpharma
May 11, 2020ANDA212182 Fluvoxamine maleate
FLUVOXAMINE MALEATE		Bionpharma
November 20, 2019ANDA210920 Deferasirox
DEFERASIROX		Bionpharma
October 7, 2019ANDA209366 Acyclovir
ACYCLOVIR		Adaptis
September 13, 2019ANDA208670 Colesevelam hydrochloride
COLESEVELAM HYDROCHLORIDE		Bionpharma
August 7, 2019ANDA206455 OMEGA-3-ACID ethyl esters
OMEGA-3-ACID ETHYL ESTERS		Chartwell
April 23, 2019ANDA211388 Rufinamide
RUFINAMIDE		Bionpharma
February 26, 2019ANDA210000 Azithromycin
AZITHROMYCIN		Bionpharma
February 26, 2019ANDA210001 Azithromycin
AZITHROMYCIN		Bionpharma
December 26, 2018ANDA209999 Azithromycin
AZITHROMYCIN		Bionpharma
October 22, 2018ANDA208819 Clobazam
CLOBAZAM		Bionpharma
April 10, 2018ANDA208625 Dofetilide
DOFETILIDE		Bionpharma
December 18, 2017ANDA208826 Tetrabenazine
TETRABENAZINE		Bionpharma
December 11, 2017ANDA202547 Aripiprazole
ARIPIPRAZOLE		Orbion Pharms
January 11, 2017ANDA204722 Rizatriptan benzoate
RIZATRIPTAN BENZOATE		Panacea
March 2, 2015ANDA202937 Olanzapine
OLANZAPINE		Orbion Pharms
June 10, 2014ANDA091113 Eszopiclone
ESZOPICLONE		Orbion Pharms
March 27, 2014ANDA202539 Paricalcitol
PARICALCITOL		Bionpharma
August 16, 2013ANDA200900 Progesterone
PROGESTERONE		Bionpharma
May 24, 2013ANDA091174 Calcitriol
CALCITRIOL		Bionpharma
November 28, 2012ANDA079229 Ropinirole
ROPINIROLE HYDROCHLORIDE		Orbion Pharms
September 26, 2012ANDA078963 Modafinil
MODAFINIL		Orbion Pharms
April 30, 2012ANDA091441 Naratriptan
NARATRIPTAN		Orbion Pharms
March 19, 2012ANDA078998 Ibandronate sodium
IBANDRONATE SODIUM		Orbion Pharms
February 19, 2010ANDA078357 Desloratadine
DESLORATADINE		Orbion Pharms
September 17, 2009ANDA090374 Zaleplon
ZALEPLON		Orbion Pharms
August 10, 2009ANDA078284 Sumatriptan
SUMATRIPTAN SUCCINATE		Orbion Pharms
January 16, 2009ANDA079120 Levetiracetam
LEVETIRACETAM		Bionpharma
November 25, 2008ANDA078853 Divalproex sodium
DIVALPROEX SODIUM		Orbion Pharms
October 6, 2008ANDA078488 Cetirizine
CETIRIZINE HYDROCHLORIDE		Bionpharma
May 29, 2008ANDA078720 Amantadine
AMANTADINE HYDROCHLORIDE		Bionpharma
February 13, 2008ANDA078678 Granisetron
GRANISETRON HYDROCHLORIDE		Orbion Pharms
January 17, 2008ANDA076740 Nimodipine
NIMODIPINE		Bionpharma
July 2, 2007ANDA078163 Terbinafine hydrochloride
TERBINAFINE HYDROCHLORIDE		Orbion Pharms
October 28, 2002ANDA040430 Ethosuximide
ETHOSUXIMIDE		Bionpharma
July 28, 2000ANDA075667 Terazosin hydrochloride
TERAZOSIN HYDROCHLORIDE		Bionpharma
June 29, 1993ANDA073484 Valproic acid
VALPROIC ACID		Bionpharma
January 29, 1993ANDA081297 Benzonatate
BENZONATATE		Bionpharma
October 16, 1978ANDA080704 Ergocalciferol
VITAMIN D		Bionpharma

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

Recall timeline

2026

  1. August 7, 2026 · Class III · Ongoing · D-0822-2026 · Doxylamine succinate and pyridoxine hydrochloride

    Presence of Foreign Tablets/Capsules

    Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 69452-206-20.

  2. June 26, 2026 · Class II · Ongoing · D-0742-2026 · Divalproex sodium

    Presence of Foreign Tablets/Capsules

    Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30.

2024

  1. September 17, 2024 · Class I · Terminated · D-0012-2025 · Atovaquone

    Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.

    Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.

2019

  1. July 16, 2019 · Class II · Terminated · D-1519-2019 · Clobazam

    Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.

    Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road, Princeton, NJ 08540, NDC 69452-116-45.

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

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