Welchol
- Product NDC
- 0713-0879
- 11-digit product format
- 007130879
- Labeler code
- 0713
- Product ID
- 0713-0879_285004c5-f33a-aaa1-e063-6394a90aac01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- colesevelam hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- NDA021176
- Marketing category
- NDA
- Marketing start
- 2022-09-01
- 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
- Welchol
- 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 | 866905, 866907, 866910, 866912 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0713-0879-81 | Welchol | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0713-0879 | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [COSETTE PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20241204_89cbd0a3-2d1b-41db-8c97-35ec67b7b09f.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 |
|---|
| 0713-0879-81 | 00713087981 | 180 TABLET, FILM COATED in 1 BOTTLE (0713-0879-81) | 2022-09-01 | 0000-00-00 | No | No | Current |