Drug company (FDA labeler)
Natco Pharma USA LLC
NDC labeler code: 69339
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
- AlprazolamXanax, Xanax XR · 4 products
- CarboplatinKyxata · 4 products
- ArmodafinilNuvigil · 4 products
- DiazepamValium, Valtoco · 3 products
- PaclitaxelPaclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound), Paclitaxel 100mg Per Vial, Abraxane · 3 products
- NitroglycerinNitrostat, Nitro-Dur, Nitroglycerin in Dextrose · 3 products
- LubiprostoneAmitiza, Amitza · 2 products
- Ondansetron2 products
- TeriflunomideAubagio · 2 products
- Bisoprolol fumarate2 products
- GefitinibIressa · 1 product
- DesloratadineClarinex · 1 product
- Chlorhexidine gluconatePeriogard Alcohol Free, Dash Chlorhexidine Gluconate 0.12% Oral Rinse, Chlorhexidine Gluconate 0.12% Oral Rinse · 1 product
- LevetiracetamKeppra, Spritam, Keppra XR · 1 product
- ItraconazoleTolsura, Sporanox · 1 product
- Megestrol acetate1 product
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.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| May 31, 2023 | ANDA212827 | Gefitinib GEFITINIB | Natco |
| May 15, 2023 | ANDA209555 | Teriflunomide TERIFLUNOMIDE | Natco |
| September 1, 2020 | ANDA212239 | Itraconazole ITRACONAZOLE | Annora Pharma |
| December 26, 2019 | ANDA211998 | Diazepam DIAZEPAM | Regcon Holdings |
| April 30, 2019 | ANDA211604 | Nitroglycerin NITROGLYCERIN | Natco |
| March 18, 2019 | ANDA210363 | Diazepam DIAZEPAM | Regcon Holdings |
| November 28, 2016 | ANDA202768 | Armodafinil ARMODAFINIL | Natco Pharma Ltd |
| April 15, 2015 | ANDA200739 | Alprazolam ALPRAZOLAM | Natco |
| February 28, 2013 | ANDA203052 | Levetiracetam LEVETIRACETAM | Hetero Labs Ltd III |
| February 10, 2012 | ANDA078351 | Desloratadine DESLORATADINE | Natco Pharma USA |
| September 29, 2011 | ANDA091540 | Paclitaxel PACLITAXEL | Natco Pharma USA |
| June 25, 2007 | ANDA077851 | Ondansetron ONDANSETRON HYDROCHLORIDE | Natco Pharma Ltd |
| January 18, 2007 | ANDA077861 | Carboplatin CARBOPLATIN | Teyro Labs |
| January 31, 2006 | NDA021908 | Lubiprostone AMITIZA | Sucampo Pharma LLC |
| December 14, 2005 | ANDA075831 | Bisoprolol fumarate BISOPROLOL FUMARATE | Natco Pharma USA |
| July 25, 2001 | ANDA075671 | Megestrol acetate MEGESTROL ACETATE | Strides Pharma Intl |
| December 28, 1995 | ANDA074291 | Chlorhexidine gluconate CHLORHEXIDINE GLUCONATE | Lyne |
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
- All drug companiesA to Z
- 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