SEVELAMER CARBONATE
- Product NDC
- 42571-378
- 11-digit product format
- 425710378
- Labeler code
- 42571
- Product ID
- 42571-378_d807f196-f1f8-0a8f-e053-2a95a90aab8d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SEVELAMER CARBONATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Micro Labs Limited
- Application
- ANDA215537
- Marketing category
- ANDA
- Marketing start
- 2022-05-01
- Substance
- SEVELAMER CARBONATE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SEVELAMER CARBONATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SEVELAMER CARBONATE | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9YCX42I8IU |
| Rxcui | 749206 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42571-378-30 | SEVELAMER CARBONATE | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 42571-378-43 | SEVELAMER CARBONATE | 270 in 1 BOTTLE | TABLET | 270 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42571-378 | SEVELAMER CARBONATE (SEVELAMER CARBONATE) TABLET [MICRO LABS LIMITED] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220501_9977f652-b3e7-43bc-bf3f-1f54698c5f7a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42571-378-30 | 42571037830 | 30 TABLET in 1 BOTTLE (42571-378-30) | 30 tablet | 2022-05-01 | 0000-00-00 | No | No | Current |
| 42571-378-43 | 42571037843 | 270 TABLET in 1 BOTTLE (42571-378-43) | 270 tablet | 2022-05-01 | 0000-00-00 | No | No | Current |