SEVELAMER HYDROCHLORIDE
- Product NDC
- 59651-087
- 11-digit product format
- 596510087
- Labeler code
- 59651
- Product ID
- 59651-087_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
- 400 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| GLS2PGI8QG | SEVELAMER HYDROCHLORIDE | 152751-57-0 | SEVELAMER HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-087-36 | 59651008736 | 360 TABLET, FILM COATED in 1 BOTTLE (59651-087-36) | 2023-07-11 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| SEVELAMER HYDROCHLORIDE | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 2024-01-24 | Human Prescription Drug Label | 2 |