Pantoprazole Sodium
- Product NDC
- 80425-0278
- 11-digit product format
- 804250278
- Labeler code
- 80425
- Product ID
- 80425-0278_2a9bf621-afb8-7627-e063-6294a90a77a9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pantoprazole Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA202882
- Marketing category
- ANDA
- Marketing start
- 2023-02-28
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 6871619Q5X | PANTOPRAZOLE SODIUM | 164579-32-2 | PANTOPRAZOLE SODIUM |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0278-1 | 80425027801 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0278-1) | 2023-03-30 | No | No | Historical |
| 80425-0278-2 | 80425027802 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0278-2) | 2023-02-28 | No | No | Historical |
| 80425-0278-3 | 80425027803 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0278-3) | 2023-02-28 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Pantoprazole Sodium Tablets DR | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 3 |