Pantoprazole Sodium
- Product NDC
- 48433-081
- 11-digit product format
- 484330081
- Labeler code
- 48433
- Product ID
- 48433-081_4ee49539-03c9-151e-e063-6294a90ab13a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pantoprazole sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Safecor Health LLC
- Application
- ANDA090970
- Marketing category
- ANDA
- Marketing start
- 2026-03-13
- Substance
- PANTOPRAZOLE SODIUM
- Active strength
- 40 mg/1
- Pharmacologic classes
- Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pantoprazole Sodium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PANTOPRAZOLE SODIUM | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6871619Q5X |
| Rxcui | 314200 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 48433-081-01 | Pantoprazole Sodium | 1 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 1 | | 2 |
| 48433-081-20 | Pantoprazole Sodium | 100 in 1 CARTON | TABLET, DELAYED RELEASE | 100 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 48433-081-01 | 48433008101 | 1 in 1 BLISTER PACK | | | | | Historical |
| 48433-081-20 | 48433008120 | 100 BLISTER PACK in 1 CARTON (48433-081-20) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (48433-081-01) | 100 blister pack | 2026-03-13 | No | No | Current |