COLESEVELAM HYDROCHLORIDE
- Product NDC
- 69452-158
- 11-digit product format
- 694520158
- Labeler code
- 69452
- Product ID
- 69452-158_30b35341-6379-12e6-e063-6394a90ad2c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- colesevelam hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA208670
- Marketing category
- ANDA
- Marketing start
- 2019-12-02
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- COLESEVELAM HYDROCHLORIDE
- Listing expiration
- 2026-12-31
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 |
|---|
| 69452-158-25 | COLESEVELAM HYDROCHLORIDE | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69452-158 | COLESEVELAM HYDROCHLORIDE TABLET, FILM COATED [BIONPHARMA INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20250322_a2c5e881-2901-4f90-95cc-74930569e51e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69452-158-25 | 69452015825 | 180 TABLET, FILM COATED in 1 BOTTLE (69452-158-25) | 2019-12-02 | 0000-00-00 | No | No | Current |