Drug company (FDA labeler)
Natco Pharma Limited
NDC labeler code: 63850
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 · 8 products
- PomalidomidePomalyst · 4 products
- Trihexyphenidyl hydrochloride2 products
- Ondansetron2 products
- LetrozoleFemara · 1 product
- AnastrozoleArimidex · 1 product
- GranisetronGranisol, Sancuso, Sustol · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| May 20, 2021 | ANDA205432 | Everolimus EVEROLIMUS | Breckenridge |
| March 5, 2021 | ANDA205426 | Everolimus EVEROLIMUS | Breckenridge |
| October 30, 2020 | ANDA210111 | Pomalidomide POMALIDOMIDE | Breckenridge |
| June 3, 2011 | ANDA200161 | Letrozole LETROZOLE | Natco Pharma Ltd |
| November 17, 2010 | ANDA091630 | Trihexyphenidyl hydrochloride TRIHEXYPHENIDYL HYDROCHLORIDE | Natco Pharma Ltd |
| June 28, 2010 | ANDA079220 | Anastrozole ANASTROZOLE | Natco Pharma Ltd |
| June 22, 2009 | ANDA078969 | Granisetron GRANISETRON HYDROCHLORIDE | Natco Pharma |
| June 25, 2007 | ANDA077851 | Ondansetron ONDANSETRON HYDROCHLORIDE | Natco Pharma Ltd |
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.
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
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- All prescription drugs A to ZSearch by generic, brand or Spanish name
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