Pantoprazole Sodium
- Product NDC
- 35573-428
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pantoprazole Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Burel Pharmaceuticals, LLC
- Application
- ANDA202038
- Marketing category
- ANDA
- Substance
- PANTOPRAZOLE SODIUM
- Current FDA listing
- Yes
Related Records
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|---|---|---|---|---|
| 35573-428-80 | 10 BLISTER PACK in 1 CARTON (35573-428-80) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 2020-04-20 | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|---|---|---|---|
| These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000 | Burel Pharmaceuticals, LLC | Aurobindo Pharma Limited | 2026-02-06 | Human Prescription Drug Label | 9 |