PANTOPRAZOLE SODIUM
- Product NDC
- 71610-659
- 11-digit product format
- 716100659
- Labeler code
- 71610
- Product ID
- 71610-659_269544ac-1dea-4047-87e6-6e04ff951b55
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PANTOPRAZOLE
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA202882
- Marketing category
- ANDA
- Marketing start
- 2022-05-01
- 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 |
|---|
| 71610-659-09 | 71610065909 | 9000 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-659-09) | 2022-08-25 | No | No | Historical |
| 71610-659-42 | 71610065942 | 1800 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-659-42) | 2023-02-17 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| PANTOPRAZOLE SODIUM | Aphena Pharma Solutions - Tennessee, LLC | 2023-02-17 | HUMAN PRESCRIPTION DRUG LABEL | 2 |