Colesevelam Hydrochloride
- Product NDC
- 33342-197
- 11-digit product format
- 333420197
- Labeler code
- 33342
- Product ID
- 33342-197_c2075dd1-e33c-4438-95f8-1897f0e1f61a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colesevelam Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA204893
- Marketing category
- ANDA
- Marketing start
- 2025-04-18
- 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 |
|---|
| 33342-197-57 | Colesevelam Hydrochloride | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-197 | COLESEVELAM HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 1 | Current NDC, 1 package rows | 20250515_c2075dd1-e33c-4438-95f8-1897f0e1f61a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 33342-197-57 | 33342019757 | 180 TABLET, FILM COATED in 1 BOTTLE (33342-197-57) | 2025-04-18 | No | No | Current |