Drug company (FDA labeler)
Anthea Pharma Private Limited
NDC labeler code: 83854
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
- Bupivacaine hydrochlorideSensorcaine Mpf, Marcaine, Sensorcaine · 5 products
- LidocaineXylocaine Mpf, Xylocaine, Lidocaine Viscous · 4 products
- Ketorolac tromethamineAcuvail, Sprix, Ketrolac Tromethamine · 3 products
- Ropivacaine hydrochlorideNaropin · 3 products
- BumetanideBumex, Enbumyst · 2 products
- PropofolDiprivan · 1 product
- LacosamideVimpat, Motpoly XR · 1 product
- Norepinephrine bitartrateLevophed · 1 product
- Fluorescein (fluorescein sodium)Ak-Fluor · 1 product
- Sodium bicarbonate1 product
- OlanzapineZyprexa, Zyprexa Zydis, Olanzapine Intramuscular · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| September 25, 2026 | ANDA221041 | Ketorolac tromethamine KETOROLAC TROMETHAMINE | Anthea Pharma |
| July 14, 2026 | ANDA220857 | Propofol PROPOFOL | Anthea Pharma |
| June 1, 2026 | ANDA218651 | Fluorescein (fluorescein sodium) FLUORESCEIN SODIUM | Zydus Lifesciences |
| April 22, 2026 | ANDA220493 | Bupivacaine hydrochloride BUPIVACAINE HYDROCHLORIDE | Anthea Pharma |
| March 5, 2026 | ANDA220323 | Olanzapine OLANZAPINE | Anthea Pharma |
| February 26, 2026 | ANDA220427 | Bumetanide BUMETANIDE | Anthea Pharma |
| January 21, 2026 | ANDA220268 | Lacosamide LACOSAMIDE | Glenmark Pharms |
| November 25, 2025 | ANDA219924 | Norepinephrine bitartrate NOREPINEPHRINE BITARTRATE | Anthea Pharma |
| June 26, 2025 | ANDA219701 | Sodium bicarbonate SODIUM BICARBONATE | Anthea Pharma |
| April 2, 2025 | ANDA219535 | Lidocaine LIDOCAINE HYDROCHLORIDE | Anthea Pharma |
| March 21, 2025 | ANDA219883 | Ropivacaine hydrochloride ROPIVACAINE HYDROCHLORIDE | Anthea Pharma |
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