SEVELAMER HYDROCHLORIDE
- Product NDC
- 59651-088
- 11-digit product format
- 596510088
- Labeler code
- 59651
- Product ID
- 59651-088_7a6f6abf-8a91-423e-8f2f-de1b3a019e7b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SEVELAMER HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA212599
- Marketing category
- ANDA
- Marketing start
- 2023-07-11
- 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 | 857216, 857224 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-088-18 | SEVELAMER HYDROCHLORIDE | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-088 | SEVELAMER HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | Current NDC, 1 package rows | 20240126_d8729e42-dbbd-4954-9ce0-298743a15a06.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-088-18 | 59651008818 | 180 TABLET, FILM COATED in 1 BOTTLE (59651-088-18) | 2023-07-11 | No | No | Current |