Colesevelam hydrochloride
- Product NDC
- 27808-190
- 11-digit product format
- 278080190
- Labeler code
- 27808
- Product ID
- 27808-190_47df1b20-2cfd-483e-94cc-232339869d17
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colesevelam hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cranbury Pharmaceuticals, LLC
- Application
- ANDA209946
- Marketing category
- ANDA
- Marketing start
- 2020-10-19
- 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 |
|---|
| 27808-190-01 | Colesevelam hydrochloride | 180 in 1 BOTTLE | TABLET | 180 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27808-190 | COLESEVELAM HYDROCHLORIDE TABLET [TRIS PHARMA INC] | 13 | Current NDC, Legacy NDC, 1 package rows | 20221102_5e50cc0c-03bc-444b-9d15-ea112bc0f91c.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 |
|---|
| 27808-190-01 | 27808019001 | 180 TABLET in 1 BOTTLE (27808-190-01) | 180 tablet | 2020-10-19 | 0000-00-00 | No | No | Current |