Sevelamer carbonate
- Product NDC
- 68475-010
- 11-digit product format
- 684750010
- Labeler code
- 68475
- Product ID
- 68475-010_d3c74ca1-7175-40a4-b96f-f864b7f47846
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sevelamer carbonate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Navinta LLC
- Application
- ANDA219931
- Marketing category
- ANDA
- Marketing start
- 2025-11-01
- Substance
- SEVELAMER CARBONATE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sevelamer carbonate
- Listing expiration
- 2027-12-31
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 |
|---|
| 68475-010-01 | Sevelamer carbonate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 68475-010-02 | Sevelamer carbonate | 270 in 1 BOTTLE | TABLET, FILM COATED | 270 | | 2 |
| 68475-010-03 | Sevelamer carbonate | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68475-010-01 | 68475001001 | 30 TABLET, FILM COATED in 1 BOTTLE (68475-010-01) | 2025-11-01 | No | No | Current |
| 68475-010-02 | 68475001002 | 270 TABLET, FILM COATED in 1 BOTTLE (68475-010-02) | 2025-11-01 | No | No | Current |
| 68475-010-03 | 68475001003 | 180 TABLET, FILM COATED in 1 BOTTLE (68475-010-03) | 2026-01-02 | No | No | Current |