Welchol
- Product NDC
- 65597-902
- 11-digit product format
- 655970902
- Labeler code
- 65597
- Product ID
- 65597-902_3e806127-4a87-41cc-9b17-a77e20bb2452
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- colesevelam hydrochloride
- Dosage form
- FOR SUSPENSION
- Route
- ORAL
- Labeler
- Daiichi Sankyo Inc.
- Application
- NDA022362
- Marketing category
- NDA
- Marketing start
- 2010-01-01
- Marketing end
- 2026-02-28
- 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
- 0000-00-00
- 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 | 65597-902 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 65597-902 | 65597-902-30 | 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 |
|---|
| 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| COLESEVELAM HYDROCHLORIDE | 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | | RLD | 2009-10-02 |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 Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| COLESEVELAM HYDROCHLORIDE | ACTIVE INGREDIENT | P4SG24WI5Q | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [DAIICHI SANKYO, INC.] | 17 | |
| COLESEVELAM | ACTIVE MOIETY | 1XU104G55N | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [DAIICHI SANKYO, INC.] | 17 | |
| COLESEVELAM HYDROCHLORIDE | ACTIVE INGREDIENT | P4SG24WI5Q | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| COLESEVELAM | ACTIVE MOIETY | 1XU104G55N | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| HYPROMELLOSE 2208 (15000 MPA.S) | INACTIVE INGREDIENT | Z78RG6M2N2 | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| MAGNESIUM TRISILICATE | INACTIVE INGREDIENT | C2E1CI501T | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| PROPYLENE GLYCOL ALGINATE | INACTIVE INGREDIENT | 26CD3J2R0C | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| COLESEVELAM HYDROCHLORIDE | ACTIVE INGREDIENT | P4SG24WI5Q | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| COLESEVELAM | ACTIVE MOIETY | 1XU104G55N | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| CAPRYLIC/CAPRIC MONO/DIGLYCERIDES | INACTIVE INGREDIENT | U72Q2I8C85 | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM TRISILICATE | INACTIVE INGREDIENT | C2E1CI501T | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| PROPYLENE GLYCOL ALGINATE | INACTIVE INGREDIENT | 26CD3J2R0C | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65597-902 | 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 |
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 |
|---|
| 65597-902-30 | 65597090230 | 30 PACKET in 1 CARTON (65597-902-30) > 1 FOR SUSPENSION in 1 PACKET | 30 packet | 2010-01-01 | 0000-00-00 | No | No | Current |