Pantoprazole
- Product NDC
- 80425-0552
- 11-digit product format
- 804250552
- Labeler code
- 80425
- Product ID
- 80425-0552_4136d849-f075-057c-e063-6394a90a91f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pantoprazole
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA077619
- Marketing category
- ANDA
- Marketing start
- 2025-10-15
- 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
- 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 |
|---|
| 80425-0552-1 | Pantoprazole | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 1 |
| 80425-0552-2 | Pantoprazole | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | | 1 |
| 80425-0552-3 | Pantoprazole | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0552-1 | 80425055201 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0552-1) | 2025-10-15 | No | No | Current |
| 80425-0552-2 | 80425055202 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0552-2) | 2025-10-15 | No | No | Current |
| 80425-0552-3 | 80425055203 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0552-3) | 2025-10-15 | No | No | Current |