COLESEVELAM HYDROCHLORIDE
- Product NDC
- 69452-493
- 11-digit product format
- 694520493
- Labeler code
- 69452
- Product ID
- 69452-493_4aa52a76-fe49-5557-e063-6294a90ace04
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- colesevelam hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA208670
- Marketing category
- ANDA
- Marketing start
- 2026-02-12
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- COLESEVELAM HYDROCHLORIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| COLESEVELAM HYDROCHLORIDE | 625 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P4SG24WI5Q |
| Rxcui | 866910 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69452-493-25 | COLESEVELAM HYDROCHLORIDE | 180 in 1 BOTTLE | TABLET | 180 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69452-493-25 | 69452049325 | 180 TABLET in 1 BOTTLE (69452-493-25) | 180 tablet | 2026-02-12 | No | No | Current |