Biocon Pharma Inc.
NDC labeler code: 70377
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.
Prescription medicines
- EverolimusYulithira, Zortress, Afinitor · 11 products
- DasatinibSprycel, Phyrago · 6 products
- LenalidomideRevlimid · 6 products
- SimvastatinZocor · 5 products
- Mycophenolic acidMyfortic · 4 products
- RosuvastatinCrestor · 4 products
- Pravastatin sodium4 products
- AtorvastatinLipitor · 4 products
- LabetalolLabetalol HCL in Dextrose · 4 products
- EltrombopagPromacta · 4 products
- Prazosin hydrochloride3 products
- Liothyronine sodiumCytomel, Liomny · 3 products
- TacrolimusPrograf, Envarsus XR, Astagraf XL · 3 products
- Aminocaproic acid3 products
- Sacubitril and valsartanEntresto · 3 products
- TeriflunomideAubagio · 2 products
- TriamtereneDyrenium · 2 products
- Dapagliflozin (dapagliflozin 2,3-butanediol monohydrate)2 products
- Sertraline hydrochlorideZoloft · 2 products
- EsomeprazoleNexium · 2 products
- Micafungin2 products
- LiraglutideVictoza, Saxenda · 2 products
- PosaconazoleNoxafil · 1 product
- FamotidinePepcid · 1 product
- Norepinephrine bitartrateLevophed · 1 product
- DeflazacortJaythari, Emflaza, Kymbee · 1 product
- TofacitinibXeljanz, Xeljanz XR · 1 product
- OxcarbazepineTrileptal, Oxtellar XR · 1 product
- DaptomycinDapzura Rt · 1 product
- FingolimodGilenya · 1 product
- Nitrofurantoin1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| May 28, 2026 | ANDA220709 | Deflazacort DEFLAZACORT | Biocon Pharma |
| April 28, 2026 | ANDA220660 | Eltrombopag ELTROMBOPAG OLAMINE | Biocon Pharma |
| April 6, 2026 | ANDA211470 | Dapagliflozin (dapagliflozin 2,3-butanediol monohydrate) DAPAGLIFLOZIN | Biocon Pharma |
| March 11, 2026 | ANDA215245 | Liraglutide LIRAGLUTIDE | Biocon Pharma |
| February 24, 2026 | ANDA217063 | Liraglutide LIRAGLUTIDE | Biocon Pharma |
| January 20, 2026 | ANDA218342 | Sertraline hydrochloride SERTRALINE HYDROCHLORIDE | Umedica |
| January 9, 2026 | ANDA217216 | Everolimus EVEROLIMUS | Biocon Pharma |
| November 17, 2025 | ANDA219442 | Tofacitinib TOFACITINIB CITRATE | Biocon Pharma |
| April 9, 2025 | ANDA216140 | Everolimus EVEROLIMUS | Biocon Pharma |
| March 21, 2025 | ANDA219443 | Norepinephrine bitartrate NOREPINEPHRINE BITARTRATE | Biocon Pharma |
| March 3, 2025 | ANDA215759 | Lenalidomide LENALIDOMIDE | Biocon Pharma |
| March 3, 2025 | ANDA217217 | Dasatinib DASATINIB | Biocon Pharma |
| October 28, 2024 | ANDA218346 | Nitrofurantoin NITROFURANTOIN | Biocon Pharma |
| August 30, 2024 | ANDA213680 | Sacubitril and valsartan SACUBITRIL AND VALSARTAN | Biocon Pharma |
| August 29, 2024 | ANDA217215 | Daptomycin DAPTOMYCIN | Biocon Pharma |
| May 29, 2024 | ANDA216438 | Micafungin MICAFUNGIN SODIUM | Biocon Pharma |
| March 1, 2024 | ANDA218278 | Oxcarbazepine OXCARBAZEPINE | Biocon Pharma |
| February 6, 2024 | ANDA218070 | Liothyronine sodium LIOTHYRONINE SODIUM | Biocon Pharma |
| November 29, 2023 | ANDA217031 | Mycophenolic acid MYCOPHENOLATE SODIUM | Biocon Pharma |
| July 7, 2023 | ANDA217137 | Famotidine FAMOTIDINE | Carnegie |
| March 13, 2023 | ANDA209639 | Teriflunomide TERIFLUNOMIDE | Biocon Pharma |
| November 23, 2022 | ANDA216436 | Atorvastatin ATORVASTATIN CALCIUM | Biocon Pharma |
| October 21, 2022 | ANDA213406 | Prazosin hydrochloride PRAZOSIN HYDROCHLORIDE | Appco |
| July 6, 2022 | ANDA214768 | Triamterene TRIAMTERENE | Biocon Generics |
| February 4, 2022 | ANDA214476 | Posaconazole POSACONAZOLE | Biocon Pharma |
| November 29, 2021 | ANDA214630 | Mycophenolic acid MYCOPHENOLATE SODIUM | Biocon Pharma |
| March 19, 2021 | ANDA213486 | Esomeprazole ESOMEPRAZOLE MAGNESIUM | Graviti Pharms |
| February 12, 2021 | ANDA213928 | Aminocaproic acid AMINOCAPROIC ACID | Pharmobedient |
| February 11, 2021 | ANDA214182 | Everolimus EVEROLIMUS | Biocon Pharma |
| January 26, 2021 | ANDA214140 | Aminocaproic acid AMINOCAPROIC ACID | Carnegie |
| November 10, 2020 | ANDA212297 | Tacrolimus TACROLIMUS | Biocon Pharma |
| December 4, 2019 | ANDA207979 | Fingolimod FINGOLIMOD HYDROCHLORIDE | Biocon Ltd |
| June 20, 2018 | ANDA209603 | Labetalol LABETALOL HYDROCHLORIDE | Appco |
| April 13, 2018 | ANDA209869 | Pravastatin sodium PRAVASTATIN SODIUM | Biocon Pharma |
| October 31, 2016 | ANDA207752 | Rosuvastatin ROSUVASTATIN CALCIUM | Biocon Pharma |
| December 20, 2006 | ANDA078034 | Simvastatin SIMVASTATIN | Biocon Pharma |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2026
-
March 27, 2026 · Class II · Ongoing · D-0420-2026 · Prazosin hydrochloride
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11.
-
March 27, 2026 · Class II · Ongoing · D-0419-2026 · Prazosin hydrochloride
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11.
-
March 27, 2026 · Class II · Ongoing · D-0421-2026 · Prazosin hydrochloride
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-068-11.
2025
-
March 17, 2025 · Class II · Ongoing · D-0306-2025 · Atorvastatin
Failed dissolution specifications: lower than specifications
Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377
2023
-
January 31, 2023 · Class II · Terminated · D-0268-2023 · Posaconazole
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009; Manufactured by: Biocon Pharma Limited, Bengaluru, India - 560 099, NDC 70377-038-11.
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
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026