SEVELAMER CARBONATE
- Product NDC
- 58624-5001
- 11-digit product format
- 586245001
- Labeler code
- 58624
- Product ID
- 58624-5001_ff5f602e-c050-40d7-81f5-1c8dfba1d32f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SEVELAMER CARBONATE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Shandong Xinhua Pharmaceutical Co., Ltd.
- Application
- ANDA215998
- Marketing category
- ANDA
- Marketing start
- 2025-02-27
- 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 |
|---|
| 58624-5001-2 | SEVELAMER CARBONATE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 7 |
| 58624-5001-4 | SEVELAMER CARBONATE | 18399 in 1 CARTON | TABLET, FILM COATED | 18399 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58624-5001 | SEVELAMER CARBONATE TABLET, FILM COATED [SHANDONG XINHUA PHARMACEUTICAL CO., LTD.] | 2 | Current NDC, 2 package rows | 20250410_f6455fa3-ad53-f6fd-e053-2a95a90a67db.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 58624-5001-2 | 58624500102 | 30 TABLET, FILM COATED in 1 BOTTLE (58624-5001-2) | 2025-02-27 | No | No | Historical |
| 58624-5001-4 | 58624500104 | 18399 TABLET, FILM COATED in 1 CARTON (58624-5001-4) | 2025-02-27 | No | No | Historical |