Colesevelam
- Product NDC
- 68382-619
- 11-digit product format
- 683820619
- Labeler code
- 68382
- Product ID
- 68382-619_bf6a10ac-0317-4804-a504-cd00e522dc65
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colesevelam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA207765
- Marketing category
- ANDA
- Marketing start
- 2019-10-11
- 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
- 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 |
|---|
| 68382-619-10 | Colesevelam | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 6 |
| 68382-619-28 | Colesevelam | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 6 |
| 68382-619-30 | Colesevelam | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 6 |
| 68382-619-77 | Colesevelam | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-619 | COLESEVELAM TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20230917_6a26e745-7e38-4af0-9bcc-566b2812df75.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-619-10 | 68382061910 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-619-10) | | 2019-10-11 | 0000-00-00 | No | No | Current |
| 68382-619-28 | 68382061928 | 180 TABLET, FILM COATED in 1 BOTTLE (68382-619-28) | | 2019-10-11 | 0000-00-00 | No | No | Current |
| 68382-619-30 | 68382061930 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 68382-619-77 | 68382061977 | 10 BLISTER PACK in 1 CARTON (68382-619-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-619-30) | 10 blister pack | 2019-10-11 | 0000-00-00 | No | No | Current |