Leflunomide
- Product NDC
- 0955-1735
- 11-digit product format
- 009551735
- Labeler code
- 0955
- Product ID
- 0955-1735_b2fa424f-afd3-47b7-bf2d-44b9f0e88324
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- leflunomide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Winthrop U.S.
- Application
- NDA020905
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2015-09-07
- Marketing end
- 0000-00-00
- Substance
- LEFLUNOMIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Antirheumatic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| leflunomide | ACTIVE INGREDIENT | G162GK9U4W | LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] | 1 | |
| leflunomide | ACTIVE MOIETY | G162GK9U4W | LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] | 1 | |
| Crospovidone | INACTIVE INGREDIENT | 68401960MK | LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] | 1 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] | 1 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] | 1 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] | 1 | |
| povidones | INACTIVE INGREDIENT | FZ989GH94E | LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] | 1 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0955-1735 | LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] | 13 | Legacy NDC | 20240723_eb85de02-2964-453b-978a-26451cd1c97a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0955-1735-30 | 00955173530 | 1 BOTTLE in 1 CARTON (0955-1735-30) > 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2015-09-07 | 0000-00-00 | No | No | Current |