Sevelamer Hydrochloride
- Product NDC
- 70710-2058
- 11-digit product format
- 707102058
- Labeler code
- 70710
- Product ID
- 70710-2058_f9b9e637-d236-4bc0-afca-bbbf1b1747ab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sevelamer Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA218966
- Marketing category
- ANDA
- Marketing start
- 2025-03-01
- Substance
- SEVELAMER HYDROCHLORIDE
- 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 Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SEVELAMER HYDROCHLORIDE | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | GLS2PGI8QG |
| Rxcui | 857224 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70710-2058-8 | Sevelamer Hydrochloride | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70710-2058 | SEVELAMER HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] | 1 | Current NDC, 1 package rows | 20250302_ddecb552-5882-4e44-8fa7-37c9234dd1b9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70710-2058-8 | 70710205808 | 180 TABLET, FILM COATED in 1 BOTTLE (70710-2058-8) | 2025-03-01 | No | No | Historical |