Pantoprazole Sodium
- Product NDC
- 68071-5053
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pantoprazole Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA202038
- Marketing category
- ANDA
- Substance
- PANTOPRAZOLE SODIUM
- Current FDA listing
- Yes
Related Records
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|---|---|---|---|---|
| 68071-5053-6 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-5053-6) | 2019-09-11 | 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 | NuCare Pharmaceuticals,Inc. | 2024-06-19 | HUMAN PRESCRIPTION DRUG LABEL | 4 |