Arava
- Product NDC
- 0088-2161
- 11-digit product format
- 000882161
- Labeler code
- 0088
- Product ID
- 0088-2161_765327c7-cb5b-4637-84da-4fd9a024ad96
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- leflunomide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- sanofi-aventis U.S. LLC
- Application
- NDA020905
- Marketing category
- NDA
- Marketing start
- 1998-09-10
- Substance
- LEFLUNOMIDE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Antirheumatic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Arava
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEFLUNOMIDE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G162GK9U4W |
| Rxcui | 205284, 205285, 205286, 213377, 213379, 213380 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0088-2161-30 | Arava | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 27 |
| 0088-2161-30 | Arava | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 27 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| leflunomide | ACTIVE INGREDIENT | G162GK9U4W | ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] | 12 | |
| leflunomide | ACTIVE MOIETY | G162GK9U4W | ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] | 12 | |
| crospovidone | INACTIVE INGREDIENT | 68401960MK | ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] | 12 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] | 12 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] | 12 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] | 12 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] | 12 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] | 12 | |
| povidones | INACTIVE INGREDIENT | FZ989GH94E | ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] | 12 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] | 12 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] | 12 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] | 12 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0088-2161 | ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] | 26 | Current NDC, Legacy NDC, 2 package rows | 20241109_320f63f2-fac3-4aee-aff8-85724e00ef52.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 |
|---|
| 0088-2161-30 | 00088216130 | 1 BOTTLE in 1 CARTON (0088-2161-30) / 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 1998-09-19 | 0000-00-00 | No | No | Current |