COLESEVELAM HYDROCHLORIDE
- Product NDC
- 0713-0935
- 11-digit product format
- 007130935
- Labeler code
- 0713
- Product ID
- 0713-0935_2a324e3d-e3ac-c310-e063-6394a90a0950
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- COLESEVELAM HYDROCHLORIDE
- Dosage form
- FOR SUSPENSION
- Route
- ORAL
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- NDA022362
- Marketing category
- NDA
- Marketing start
- 2022-08-01
- 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
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 0713-0935 | | I | Inactivated by FDA | | 2026-07-31 |
| excluded package | package | 0713-0935 | 0713-0935-30 | I | Inactivated by FDA | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| N022362-001 | WELCHOL | COLESEVELAM HYDROCHLORIDE | 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | | RLD | 2009-10-02 |
| N022362-002 | WELCHOL | COLESEVELAM HYDROCHLORIDE | 3.75GM/PACKET | FOR SUSPENSION / ORAL | AB | RLD, RS | 2009-10-02 |
Therapeutic equivalence codes#
Application-product, TE code table| Application-product | TE code |
|---|
| N022362-002 | AB |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0713-0935-30 | COLESEVELAM HYDROCHLORIDE | 1 in 1 PACKET | FOR SUSPENSION | 1 | | 4 |
| 0713-0935-30 | COLESEVELAM HYDROCHLORIDE | 30 in 1 CARTON | FOR SUSPENSION | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0713-0935 | COLESEVELAM HYDROCHLORIDE TABLET, FILM COATED COLESEVELAM HYDROCHLORIDE FOR SUSPENSION [COSETTE PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241228_15ceb7db-ef59-4182-99b6-09b6c3c5430a.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 |
|---|
| 0713-0935-30 | 00713093530 | 30 PACKET in 1 CARTON (0713-0935-30) / 1 FOR SUSPENSION in 1 PACKET | 30 packet | 2022-08-01 | 0000-00-00 | No | No | Current |