Welchol
- Product NDC
- 65597-209
- 11-digit product format
- 655970209
- Labeler code
- 65597
- Product ID
- 65597-209_ccd182d4-5850-404f-8036-d5d49367b8a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- colesevelam hydrochloride
- Dosage form
- BAR, CHEWABLE
- Route
- ORAL
- Labeler
- Daiichi Sankyo Inc.
- Application
- NDA210895
- Marketing category
- NDA
- Marketing start
- 2019-04-04
- Marketing end
- 0000-00-00
- Substance
- COLESEVELAM HYDROCHLORIDE
- Active strength
- 4 g/1
- Pharmacologic classes
- Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
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 | 65597-209 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 65597-209 | 65597-209-30 | D | Discontinued by firm | | 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 |
|---|
| N210895-001 | WELCHOL | COLESEVELAM HYDROCHLORIDE | 3.75GM | BAR, CHEWABLE / ORAL | | RLD | 2019-04-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65597-209 | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION WELCHOL (COLESEVELAM HYDROCHLORIDE) BAR, CHEWABLE [DAIICHI SANKYO INC.] | 35 | Legacy NDC | 20220617_4a06d3b2-7229-4398-baba-5d0a72f63821.zip |