colesevelam hydrochloride
- Product NDC
- 75834-152
- 11-digit product format
- 758340152
- Labeler code
- 75834
- Product ID
- 75834-152_d1b13bfd-0e38-7b76-e053-2a95a90a8866
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- colesevelam hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Nivagen Pharmaceuticals, Inc.
- Application
- ANDA212050
- Marketing category
- ANDA
- Marketing start
- 2020-12-04
- Marketing end
- 0000-00-00
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75834-152 | COLESEVELAM HYDROCHLORIDE TABLET, COATED [NIVAGEN PHARMACEUTICALS, INC.] | 4 | Legacy NDC | 20230816_8867edcf-0b56-4203-8269-90b3af4ede36.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 75834-152-18 | 75834015218 | 180 TABLET, COATED in 1 BOTTLE (75834-152-18) | 2020-12-04 | 0000-00-00 | No | No | Current |