Colestipol Hydrochloride
- Product NDC
- 42799-115
- 11-digit product format
- 427990115
- Labeler code
- 42799
- Product ID
- 42799-115_440d1d49-3eb7-42db-8536-9f0a91c46532
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colestipol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Edenbridge Pharmaceuticals LLC.
- Application
- ANDA217667
- Marketing category
- ANDA
- Marketing start
- 2024-11-26
- 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 |
|---|
| 42799-115-01 | Colestipol Hydrochloride | 120 in 1 BOTTLE | TABLET | 120 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42799-115 | COLESTIPOL HYDROCHLORIDE TABLET [EDENBRIDGE PHARMACEUTICALS LLC.] | 6 | Current NDC, 1 package rows | 20241213_03ca5800-4211-4383-a332-be88bd9b5304.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42799-115-01 | 42799011501 | 120 TABLET in 1 BOTTLE (42799-115-01) | 120 tablet | 2024-11-26 | No | No | Historical |