Colesevelam hydrochloride
- Product NDC
- 0115-1864
- 11-digit product format
- 001151864
- Labeler code
- 0115
- Product ID
- 0115-1864_83f79a9e-7658-4d89-a3aa-8c5ee39ac846
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colesevelam hydrochloride
- Dosage form
- FOR SUSPENSION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA212886
- Marketing category
- ANDA
- Marketing start
- 2023-01-20
- Substance
- COLESEVELAM HYDROCHLORIDE
- Active strength
- 3.75 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
- Colesevelam hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| COLESEVELAM HYDROCHLORIDE | 3.75 g/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P4SG24WI5Q |
| Rxcui | 866905 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0115-1864-18 | Colesevelam hydrochloride | 30 in 1 CARTON | FOR SUSPENSION | 30 | | 4 |
| 0115-1864-30 | Colesevelam hydrochloride | 1 in 1 PACKET | FOR SUSPENSION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-1864 | COLESEVELAM HYDROCHLORIDE FOR SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 4 | Current NDC, 2 package rows | 20230120_f33fbf30-2486-49a7-bbe8-0ddfb4b9b786.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 |
|---|
| 0115-1864-18 | 00115186418 | 30 PACKET in 1 CARTON (0115-1864-18) / 1 FOR SUSPENSION in 1 PACKET (0115-1864-30) | 30 packet | 2023-01-20 | No | No | Historical |
| 0115-1864-30 | 00115186430 | 1 in 1 PACKET | | | | | Historical |