Colesevelam HCL
- Product NDC
- 63629-8767
- 11-digit product format
- 636298767
- Labeler code
- 63629
- Product ID
- 63629-8767_7802c4a7-198d-44ec-9bed-f480362c5d07
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colesevelam HCL
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA209038
- Marketing category
- ANDA
- Marketing start
- 2018-10-06
- 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 HCL
- 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 |
|---|
| 63629-8767-1 | Colesevelam HCL | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 105 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8767 | COLESEVELAM HCL TABLET, FILM COATED [BRYANT RANCH PREPACK] | 105 | Current NDC, Legacy NDC, 1 package rows | 20240504_5d1b8dfd-cfe7-4c86-9d7b-a709b593acf7.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 |
|---|
| 63629-8767-1 | 63629876701 | 180 TABLET, FILM COATED in 1 BOTTLE (63629-8767-1) | 2018-10-06 | 0000-00-00 | No | No | Current |