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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 6871619Q5X | PANTOPRAZOLE SODIUM | 164579-32-2 | PANTOPRAZOLE SODIUM |
| D8TST4O562 | PANTOPRAZOLE | 102625-70-7 | Pantoprazole |
Packages
| 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 | Historical |
| 80425-0552-2 | 80425055202 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0552-2) | 2025-10-15 | No | No | Historical |
| 80425-0552-3 | 80425055203 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0552-3) | 2025-10-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Pantoprazole | Advanced Rx of Tennessee, LLC | 2025-10-15 | HUMAN PRESCRIPTION DRUG LABEL | 1 |