Colesevelam HCL
- Product NDC
- 72789-476
- 11-digit product format
- 727890476
- Labeler code
- 72789
- Product ID
- 72789-476_3ba12d53-699b-c57c-e063-6294a90a8071
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colesevelam HCL
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA209038
- Marketing category
- ANDA
- Marketing start
- 2018-10-06
- 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 HCL
- 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 |
|---|
| 72789-476-93 | Colesevelam HCL | 180 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 180 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-476 | COLESEVELAM HCL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 15 | Current NDC, 1 package rows | 20250125_66a0f44e-3e68-4a67-a3d0-21a0bf99c9cb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-476-93 | 72789047693 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-476-93) | 2025-01-23 | No | No | Historical |