teriflunomide

Generic: teriflunomide

Labeler: concord biotech limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name teriflunomide
Generic Name teriflunomide
Labeler concord biotech limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

teriflunomide 14 mg/141

Manufacturer
CONCORD BIOTECH LIMITED

Identifiers & Regulatory

Product NDC 68254-5010
Product ID 68254-5010_ebb5a19c-6889-4d12-b9fd-b7dea06a52d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218663
Listing Expiration 2026-12-31
Marketing Start 2025-07-07

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 682545010
Hyphenated Format 68254-5010

Supplemental Identifiers

RxCUI
1310525 1310533
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 ANDA218663 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 14 mg/141
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (68254-5010-1)
source: ndc

Packages (1)

68254-5010-1 30 TABLET, FILM COATED in 1 BOTTLE (68254-5010-1)

Ingredients (1)

teriflunomide (14 mg/141)

Linked Drug Pages (1)

TERIFLUNOMIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ebb5a19c-6889-4d12-b9fd-b7dea06a52d0", "openfda": {"nui": ["N0000185502", "N0000185501"], "unii": ["1C058IKG3B"], "rxcui": ["1310525", "1310533"], "spl_set_id": ["2d2724f6-8812-4a26-b2ec-936b71f868e1"], "pharm_class_epc": ["Pyrimidine Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]"], "manufacturer_name": ["CONCORD BIOTECH LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68254-5010-1)", "package_ndc": "68254-5010-1", "marketing_start_date": "20250707"}], "brand_name": "TERIFLUNOMIDE", "product_id": "68254-5010_ebb5a19c-6889-4d12-b9fd-b7dea06a52d0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]", "Pyrimidine Synthesis Inhibitor [EPC]"], "product_ndc": "68254-5010", "generic_name": "TERIFLUNOMIDE", "labeler_name": "CONCORD BIOTECH LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TERIFLUNOMIDE", "active_ingredients": [{"name": "TERIFLUNOMIDE", "strength": "14 mg/141"}], "application_number": "ANDA218663", "marketing_category": "ANDA", "marketing_start_date": "20250707", "listing_expiration_date": "20261231"}