SEVELAMER CARBONATE
- Product NDC
- 11788-116
- 11-digit product format
- 117880116
- Labeler code
- 11788
- Product ID
- 11788-116_98ce69c6-ff2b-4b2e-988f-5e15d7f774e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SEVELAMER CARBONATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AiPing Pharmaceutical, Inc.
- Application
- ANDA215998
- Marketing category
- ANDA
- Marketing start
- 2025-12-15
- 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 |
|---|
| 11788-116-07 | SEVELAMER CARBONATE | 270 in 1 BOTTLE | TABLET | 270 | | 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 |
|---|
| 11788-116-07 | 11788011607 | 270 TABLET in 1 BOTTLE (11788-116-07) | 270 tablet | 2025-12-15 | No | No | Current |