COLESEVELAM HYDROCHLORIDE
- Product NDC
- 50090-6995
- 11-digit product format
- 500906995
- Labeler code
- 50090
- Product ID
- 50090-6995_a14b8135-6187-46a0-b956-af2fb764229d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- COLESEVELAM HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- NDA021176
- Marketing category
- NDA
- Marketing start
- 2022-08-01
- 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
- 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 |
|---|
| 50090-6995-0 | COLESEVELAM HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-6995 | COLESEVELAM HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 1 package rows | 20231229_0127afae-8d8d-43f2-97f9-4f99f6947e81.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6995-0 | 50090699500 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6995-0) | 2023-12-27 | No | No | Historical |