teriflunomide

Generic: teriflunomide

Labeler: teva pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name teriflunomide
Generic Name teriflunomide
Labeler teva pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

teriflunomide 7 mg/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-3157
Product ID 0480-3157_3196d973-fb6b-4da7-8f23-1f8e4f44bcf7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209700
Listing Expiration 2026-12-31
Marketing Start 2023-03-13

Pharmacologic Class

Established (EPC)
pyrimidine synthesis inhibitor [epc]
Mechanism of Action
dihydroorotate dehydrogenase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04803157
Hyphenated Format 0480-3157

Supplemental Identifiers

RxCUI
1310525 1310533
UPC
0304803157566 0304803156569
UNII
1C058IKG3B
NUI
N0000185502 N0000185501

Packaging Origin

Original Packager
true

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 ANDA209700 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0480-3157-56)
source: ndc

Packages (1)

0480-3157-56 30 TABLET, FILM COATED in 1 BOTTLE (0480-3157-56)

Ingredients (1)

teriflunomide (7 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": "3196d973-fb6b-4da7-8f23-1f8e4f44bcf7", "openfda": {"nui": ["N0000185502", "N0000185501"], "upc": ["0304803157566", "0304803156569"], "unii": ["1C058IKG3B"], "rxcui": ["1310525", "1310533"], "spl_set_id": ["c424959d-00c9-4e76-aba6-cc7464d8e903"], "pharm_class_epc": ["Pyrimidine Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0480-3157-56)", "package_ndc": "0480-3157-56", "marketing_start_date": "20230313"}], "brand_name": "Teriflunomide", "product_id": "0480-3157_3196d973-fb6b-4da7-8f23-1f8e4f44bcf7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]", "Pyrimidine Synthesis Inhibitor [EPC]"], "product_ndc": "0480-3157", "generic_name": "Teriflunomide", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Teriflunomide", "active_ingredients": [{"name": "TERIFLUNOMIDE", "strength": "7 mg/1"}], "application_number": "ANDA209700", "marketing_category": "ANDA", "marketing_start_date": "20230313", "listing_expiration_date": "20261231"}