COLESTIPOL HYDROCHLORIDE
- Product NDC
- 62559-395
- 11-digit product format
- 625590395
- Labeler code
- 62559
- Product ID
- 62559-395_f062e9d4-c5ef-411e-8f4a-6deec3ee95c7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- COLESTIPOL HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA216517
- Marketing category
- ANDA
- Marketing start
- 2023-05-15
- 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 |
|---|
| 62559-395-12 | COLESTIPOL HYDROCHLORIDE | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62559-395 | COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [ANI PHARMACEUTICALS, INC.] | 2 | Current NDC, 1 package rows | 20250206_3d380b5e-e346-4a47-ac95-faa37c6f2a51.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62559-395-12 | 62559039512 | 120 TABLET, FILM COATED in 1 BOTTLE (62559-395-12) | 2023-05-15 | No | No | Current |