Colesevelam Hydrochloride
- Product NDC
- 43598-230
- 11-digit product format
- 435980230
- Labeler code
- 43598
- Product ID
- 43598-230_1afa82f5-9ea2-5d75-688e-a44a867bd377
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colesevelam Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dr.Reddys Laboratories Inc
- Application
- ANDA210889
- Marketing category
- ANDA
- Marketing start
- 2018-10-05
- Substance
- COLESEVELAM HYDROCHLORIDE
- Active strength
- 625 mg/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 | 625 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P4SG24WI5Q |
| Rxcui | 866910 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-230-18 | Colesevelam Hydrochloride | 180 in 1 BOTTLE | TABLET | 180 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-230 | COLESEVELAM HYDROCHLORIDE TABLET [DR.REDDYS LABORATORIES INC] | 8 | Current NDC, Legacy NDC, 1 package rows | 20230916_28701657-640a-67d6-e56f-cf5c672c6e2a.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 |
|---|
| 43598-230-18 | 43598023018 | 180 TABLET in 1 BOTTLE (43598-230-18) | 180 tablet | 2018-10-05 | 0000-00-00 | No | No | Current |