Pantoprazole Sodium
- Product NDC
- 80425-0406
- 11-digit product format
- 804250406
- Labeler code
- 80425
- Product ID
- 80425-0406_1c4616ae-982f-d4b6-e063-6294a90a38f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pantoprazole Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA202038
- Marketing category
- ANDA
- Marketing start
- 2024-06-27
- Substance
- PANTOPRAZOLE SODIUM
- Active strength
- 20 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
- Brand name suffix
- DR
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PANTOPRAZOLE SODIUM | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6871619Q5X |
| Rxcui | 251872 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0406-1 | Pantoprazole SodiumDR | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 1 |
| 80425-0406-2 | Pantoprazole SodiumDR | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | | 1 |
| 80425-0406-3 | Pantoprazole SodiumDR | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0406 | PANTOPRAZOLE SODIUM DR (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [ADVANCED RX OF TENNESSEE, LLC] | 1 | Current NDC, 3 package rows | 20240704_1c46140c-2399-5ca3-e063-6394a90af33b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0406-1 | 80425040601 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0406-1) | 2024-06-27 | No | No | Historical |
| 80425-0406-2 | 80425040602 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0406-2) | 2024-06-27 | No | No | Historical |
| 80425-0406-3 | 80425040603 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0406-3) | 2024-06-27 | No | No | Historical |