Colesevelam Hydrochloride
- Product NDC
- 33342-197
- 11-digit product format
- 333420197
- Labeler code
- 33342
- Product ID
- 33342-197_c2075dd1-e33c-4438-95f8-1897f0e1f61a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colesevelam Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA204893
- Marketing category
- ANDA
- Marketing start
- 2025-04-18
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 33342-197-57 | 33342019757 | 180 TABLET, FILM COATED in 1 BOTTLE (33342-197-57) | 2025-04-18 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Colesevelam Hydrochloride | Macleods Pharmaceuticals Limited | 2025-05-05 | Human Prescription Drug Label | 1 |