Colesevelam hydrochloride
- Product NDC
- 67877-523
- 11-digit product format
- 678770523
- Labeler code
- 67877
- Product ID
- 67877-523_28be90eb-5090-4aba-ae6e-8a4332ccfbe2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colesevelam hydrochloride
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA210316
- Marketing category
- ANDA
- Marketing start
- 2019-05-09
- Substance
- COLESEVELAM HYDROCHLORIDE
- Active strength
- 3.75 g/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 | 3.75 g/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P4SG24WI5Q |
| Rxcui | 866905 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67877-523-30 | Colesevelam hydrochloride | 30 in 1 PACKET | POWDER, FOR SUSPENSION | 30 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-523 | COLESEVELAM HYDROCHLORIDE POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] | 14 | Current NDC, Legacy NDC, 1 package rows | 20230217_dfce5bc5-58fc-4fe5-b5c0-7a8026ee2b96.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 |
|---|
| 67877-523-30 | 67877052330 | 30 POWDER, FOR SUSPENSION in 1 PACKET (67877-523-30) | 2019-05-09 | 0000-00-00 | No | No | Current |