COLESTIPOL HYDROCHLORIDE
- Product NDC
- 0115-5213
- 11-digit product format
- 001155213
- Labeler code
- 0115
- Product ID
- 0115-5213_78f0e0f5-e61e-4c11-8e35-b65bcdfcfc06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- COLESTIPOL HYDROCHLORIDE
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA077277
- Marketing category
- ANDA
- Marketing start
- 2006-05-02
- Substance
- COLESTIPOL HYDROCHLORIDE
- Active strength
- 5 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 | 5 g/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X7D10K905G |
| Rxcui | 1048450 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0115-5213-02 | COLESTIPOL HYDROCHLORIDE | 100 in 1 BOTTLE | SUSPENSION | 100 | | 12 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-5213 | COLESTIPOL HYDROCHLORIDE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 12 | Current NDC, Legacy NDC, 1 package rows | 20231231_839354bd-cbac-4d18-8c02-b1b93766af38.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0115-5213-02 | 00115521302 | 100 SUSPENSION in 1 BOTTLE (0115-5213-02) | 100 suspension | 2006-05-02 | 0000-00-00 | No | No | Current |