Strides Pharma Inc.
NDC labeler code: 42543
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
- BuspironeBucapsol · 5 products
- Potassium citrateUrocit-K · 3 products
- HydrocortisoneSolu-Cortef, Proctozone-Hc, Alkindi Sprinkle · 3 products
- Mycophenolate mofetilCellcept, Myhibbin · 2 products
- AmantadineGocovri · 2 products
- Emtricitabine and tenofovir disoproxil fumarateTruvada · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| January 13, 2021 | ANDA091055 | Emtricitabine and tenofovir disoproxil fumarate EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | Strides Pharma |
| September 11, 2017 | ANDA206813 | Potassium citrate POTASSIUM CITRATE | Strides Pharma |
| June 9, 2017 | ANDA209035 | Amantadine AMANTADINE HYDROCHLORIDE | Strides Pharma |
| June 7, 2017 | ANDA209047 | Amantadine AMANTADINE HYDROCHLORIDE | Strides Pharma |
| April 27, 2017 | ANDA207029 | Hydrocortisone HYDROCORTISONE | Strides Pharma |
| August 25, 2014 | ANDA202330 | Buspirone BUSPIRONE HYDROCHLORIDE | Strides Pharma |
| June 10, 2010 | ANDA090055 | Mycophenolate mofetil MYCOPHENOLATE MOFETIL | Strides Pharma |
| June 10, 2010 | ANDA090456 | Mycophenolate mofetil MYCOPHENOLATE MOFETIL | Strides Pharma |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2018
-
July 18, 2018 · Class II · Terminated · D-1018-2018 · Potassium citrate
Failed Tablet/Capsule Specifications: Tablet breakage
Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India,
-
July 18, 2018 · Class II · Terminated · D-1017-2018 · Potassium citrate
Failed Tablet/Capsule Specifications: Tablet breakage
Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India,
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