Colestipol Hydrochloride
- Product NDC
- 50742-284
- 11-digit product format
- 507420284
- Labeler code
- 50742
- Product ID
- 50742-284_f784d09d-69b6-4e7b-a1eb-8b7e839cd4db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colestipol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Ingenus Pharmaceuticals, LLC
- Application
- ANDA217462
- Marketing category
- ANDA
- Marketing start
- 2024-12-03
- Substance
- COLESTIPOL HYDROCHLORIDE
- Active strength
- 1 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
- Colestipol Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| COLESTIPOL HYDROCHLORIDE | 1 g/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X7D10K905G |
| Rxcui | 1048445 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50742-284-12 | Colestipol Hydrochloride | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50742-284 | COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC] | 1 | Current NDC, 1 package rows | 20241219_3fa27483-8346-4145-81c0-5527204d7d68.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50742-284-12 | 50742028412 | 120 TABLET, FILM COATED in 1 BOTTLE (50742-284-12) | 2024-12-03 | No | No | Historical |