COLESTIPOL HYDROCHLORIDE
- Product NDC
- 0115-5211
- 11-digit product format
- 001155211
- Labeler code
- 0115
- Product ID
- 0115-5211_4ec79132-daa8-4439-bbd2-6f8c8c020e4f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- COLESTIPOL HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA077510
- Marketing category
- ANDA
- Marketing start
- 2021-08-17
- 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 |
|---|
| 0115-5211-02 | COLESTIPOL HYDROCHLORIDE | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 15 |
| 0115-5211-16 | COLESTIPOL HYDROCHLORIDE | 120 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 120 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| COLESTIPOL HYDROCHLORIDE | ACTIVE INGREDIENT | X7D10K905G | COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 3 | |
| COLESTIPOL | ACTIVE MOIETY | K50N755924 | COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 3 | |
| CELLACEFATE | INACTIVE INGREDIENT | F2O5O2OI9F | COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 3 | |
| COPOVIDONE K25-31 | INACTIVE INGREDIENT | D9C330MD8B | COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 3 | |
| DIBUTYL SEBACATE | INACTIVE INGREDIENT | 4W5IH7FLNY | COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 3 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 3 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-5211 | COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 14 | Current NDC, Legacy NDC, 2 package rows | 20250215_fa6c3e11-84e9-433d-aa74-7cd34336bbed.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 |
|---|
| 0115-5211-02 | 00115521102 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-5211-02) | 2021-08-17 | 0000-00-00 | No | No | Current |
| 0115-5211-16 | 00115521116 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-5211-16) | 2021-08-17 | 0000-00-00 | No | No | Current |