Colesevelam hydrochloride
- Product NDC
- 50090-7605
- 11-digit product format
- 500907605
- Labeler code
- 50090
- Product ID
- 50090-7605_5f82c8bd-3c74-446a-92b5-572f85eb6376
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colesevelam hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA209946
- Marketing category
- ANDA
- Marketing start
- 2020-10-19
- Substance
- COLESEVELAM HYDROCHLORIDE
- Active strength
- 625 mg/1
- Pharmacologic classes
- Bile Acid Sequestrant [EPC], Bile-acid Binding 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 |
|---|
| P4SG24WI5Q | COLESEVELAM HYDROCHLORIDE | 182815-44-7 | COLESEVELAM HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7605-0 | 50090760500 | 90 TABLET in 1 BOTTLE (50090-7605-0) | 90 tablet | 2025-07-16 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Colesevelam hydrochloride | A-S Medication Solutions | 2025-07-17 | HUMAN PRESCRIPTION DRUG LABEL | 1 |