Pantoprazole Sodium
- Product NDC
- 68071-1963
- 11-digit product format
- 680711963
- Labeler code
- 68071
- Product ID
- 68071-1963_1d4be162-1637-896d-e063-6394a90a39f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pantoprazole Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA090074
- Marketing category
- ANDA
- Marketing start
- 2011-01-20
- Substance
- PANTOPRAZOLE SODIUM
- Active strength
- 40 mg/1
- Pharmacologic classes
- Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pantoprazole Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PANTOPRAZOLE SODIUM | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6871619Q5X |
| Rxcui | 314200 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-1963-3 | 2024-07-15 | C162847 | 48780-1 | ba0f9c33-27d6-a910-e053-dadaa90a0b85 | 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 |
| 68071-1963-4 | 2024-07-15 | C162847 | 48780-1 | ba0f9c33-27d6-a910-e053-dadaa90a0b85 | 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 |
| 68071-1963-6 | 2024-07-15 | C162847 | 48780-1 | ba0f9c33-27d6-a910-e053-dadaa90a0b85 | 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 |
| 68071-1963-3 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-27d6-a910-e053-dadaa90a0b85 | 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 |
| 68071-1963-4 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-27d6-a910-e053-dadaa90a0b85 | 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 |
| 68071-1963-6 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-27d6-a910-e053-dadaa90a0b85 | 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 |
| 68071-1963-3 | 2021-02-23 | C162847 | 48780-1 | ba0f9c33-27d6-a910-e053-dadaa90a0b85 | 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 |
| 68071-1963-4 | 2021-02-23 | C162847 | 48780-1 | ba0f9c33-27d6-a910-e053-dadaa90a0b85 | 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 |
| 68071-1963-6 | 2021-02-23 | C162847 | 48780-1 | ba0f9c33-27d6-a910-e053-dadaa90a0b85 | 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 |
| 68071-1963-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-27d6-a910-e053-dadaa90a0b85 | 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 |
| 68071-1963-4 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-27d6-a910-e053-dadaa90a0b85 | 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 |
| 68071-1963-6 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-27d6-a910-e053-dadaa90a0b85 | 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 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-1963-3 | Pantoprazole Sodium | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 4 |
| 68071-1963-4 | Pantoprazole Sodium | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | | 4 |
| 68071-1963-6 | Pantoprazole Sodium | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-1963 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NUCARE PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 3 package rows | 20240716_4fbec80c-b38d-122c-e054-00144ff88e88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-1963-3 | 68071196303 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-1963-3) | 2011-01-20 | 0000-00-00 | No | No | Current |
| 68071-1963-4 | 68071196304 | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-1963-4) | 2011-01-20 | 0000-00-00 | No | No | Current |
| 68071-1963-6 | 68071196306 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-1963-6) | 2011-01-20 | 0000-00-00 | No | No | Current |