teriflunomide

Generic: teriflunomide

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

teriflunomide 7 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1010
Product ID 70771-1010_b7b4c7bb-e9d3-4441-a7d5-b949b1656e36
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209668
Listing Expiration 2026-12-31
Marketing Start 2023-02-14

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 707711010
Hyphenated Format 70771-1010

Supplemental Identifiers

RxCUI
1310525 1310533
UPC
0370710111533
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 ANDA209668 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (70771-1010-3)
  • 2 CARTON in 1 CARTON (70771-1010-8) / 1 BLISTER PACK in 1 CARTON (70771-1010-7) / 14 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

70771-1010-3 30 TABLET, FILM COATED in 1 BOTTLE (70771-1010-3) 70771-1010-8 2 CARTON in 1 CARTON (70771-1010-8) / 1 BLISTER PACK in 1 CARTON (70771-1010-7) / 14 TABLET, FILM COATED in 1 BLISTER PACK

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": "b7b4c7bb-e9d3-4441-a7d5-b949b1656e36", "openfda": {"nui": ["N0000185502", "N0000185501"], "upc": ["0370710111533"], "unii": ["1C058IKG3B"], "rxcui": ["1310525", "1310533"], "spl_set_id": ["58991a51-d40e-476f-8f5f-ac89e68e7107"], "pharm_class_epc": ["Pyrimidine Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70771-1010-3)", "package_ndc": "70771-1010-3", "marketing_start_date": "20230214"}, {"sample": false, "description": "2 CARTON in 1 CARTON (70771-1010-8)  / 1 BLISTER PACK in 1 CARTON (70771-1010-7)  / 14 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "70771-1010-8", "marketing_start_date": "20230214"}], "brand_name": "Teriflunomide", "product_id": "70771-1010_b7b4c7bb-e9d3-4441-a7d5-b949b1656e36", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]", "Pyrimidine Synthesis Inhibitor [EPC]"], "product_ndc": "70771-1010", "generic_name": "Teriflunomide", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Teriflunomide", "active_ingredients": [{"name": "TERIFLUNOMIDE", "strength": "7 mg/1"}], "application_number": "ANDA209668", "marketing_category": "ANDA", "marketing_start_date": "20230214", "listing_expiration_date": "20261231"}