RABEPRAZOLE SODIUM
- Product NDC
- 80425-0449
- 11-digit product format
- 804250449
- Labeler code
- 80425
- Product ID
- 80425-0449_26f90a6f-e993-0fe9-e063-6394a90af695
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rabeprazole sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA204237
- Marketing category
- ANDA
- Marketing start
- 2024-11-15
- Substance
- RABEPRAZOLE 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
- RABEPRAZOLE SODIUM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RABEPRAZOLE SODIUM | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3L36P16U4R |
| Rxcui | 854868 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0449-1 | RABEPRAZOLE SODIUM | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 1 |
| 80425-0449-2 | RABEPRAZOLE SODIUM | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | | 1 |
| 80425-0449-3 | RABEPRAZOLE SODIUM | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0449 | RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [ADVANCED RX OF TENNESSEE, LLC] | 1 | Current NDC, 3 package rows | 20241116_26f8c3bc-4402-e92c-e063-6294a90a9ad7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0449-1 | 80425044901 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0449-1) | 2024-11-15 | No | No | Historical |
| 80425-0449-2 | 80425044902 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0449-2) | 2024-11-15 | No | No | Historical |
| 80425-0449-3 | 80425044903 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0449-3) | 2024-11-15 | No | No | Historical |