Colesevelam Hydrochloride
- Product NDC
- 0115-1320
- 11-digit product format
- 001151320
- Labeler code
- 0115
- Product ID
- 0115-1320_6fbde16a-69db-42e0-9e63-86c1116ae99f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- COLESEVELAM HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA091600
- Marketing category
- ANDA
- Marketing start
- 2018-05-17
- 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 |
|---|
| 0115-1320-19 | Colesevelam Hydrochloride | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-1320 | COLESEVELAM HYDROCHLORIDE TABLET, COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 17 | Current NDC, Legacy NDC, 1 package rows | 20241120_f5306376-e7f2-44ad-8250-635b95428a7c.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 |
|---|
| 0115-1320-19 | 00115132019 | 180 TABLET, FILM COATED in 1 BOTTLE (0115-1320-19) | 2018-05-17 | 0000-00-00 | No | No | Current |