teriflunomide

Generic: teriflunomide

Labeler: SOLA Pharmaceuticals, LLC
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive

Drug Facts

Product Profile

Brand Name teriflunomide
Generic Name teriflunomide
Labeler SOLA Pharmaceuticals, LLC
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

TERIFLUNOMIDE 14 mg/1

Identifiers & Regulatory

Product NDC 70512-851
Product ID 70512-851_47e4849d-076c-a163-e063-6294a90a621f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209677
Marketing Start 2023-03-12
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70512851
Hyphenated Format 70512-851

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name teriflunomide (source: ndc)
Generic Name teriflunomide (source: ndc)
Application Number ANDA209677 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 14 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (70512-851-28) / 28 TABLET, COATED in 1 BLISTER PACK
source: ndc

Packages (1)

70512-851-28 1 BLISTER PACK in 1 CARTON (70512-851-28) / 28 TABLET, COATED in 1 BLISTER PACK

Ingredients (1)

TERIFLUNOMIDE (14 mg/1)

Linked Drug Pages (1)

teriflunomide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47e4849d-076c-a163-e063-6294a90a621f", "openfda": {"nui": ["N0000185502", "N0000185501"], "unii": ["1C058IKG3B"], "rxcui": ["1310525", "1310533"], "spl_set_id": ["8e6d1915-686c-4a57-af8a-c5ba61746821"], "pharm_class_epc": ["Pyrimidine Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]"], "manufacturer_name": ["SOLA Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (70512-851-28)  / 28 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "70512-851-28", "marketing_end_date": "20260228", "marketing_start_date": "20230312"}], "brand_name": "teriflunomide", "product_id": "70512-851_47e4849d-076c-a163-e063-6294a90a621f", "dosage_form": "TABLET, COATED", "pharm_class": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]", "Pyrimidine Synthesis Inhibitor [EPC]"], "product_ndc": "70512-851", "generic_name": "teriflunomide", "labeler_name": "SOLA Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "teriflunomide", "active_ingredients": [{"name": "TERIFLUNOMIDE", "strength": "14 mg/1"}], "application_number": "ANDA209677", "marketing_category": "ANDA", "marketing_end_date": "20260228", "marketing_start_date": "20230312"}