teriflunomide

Generic: teriflunomide

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name teriflunomide
Generic Name teriflunomide
Labeler avkare
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

teriflunomide 14 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-831
Product ID 42291-831_4875c75e-d6b3-05a5-e063-6394a90aa62f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209700
Listing Expiration 2027-12-31
Marketing Start 2023-04-20

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 42291831
Hyphenated Format 42291-831

Supplemental Identifiers

RxCUI
1310525 1310533
UPC
0342291830301 0342291831308
UNII
1C058IKG3B
NUI
N0000185502 N0000185501

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
  • 14 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (42291-831-30)
source: ndc

Packages (1)

42291-831-30 30 TABLET, FILM COATED in 1 BOTTLE (42291-831-30)

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": "4875c75e-d6b3-05a5-e063-6394a90aa62f", "openfda": {"nui": ["N0000185502", "N0000185501"], "upc": ["0342291830301", "0342291831308"], "unii": ["1C058IKG3B"], "rxcui": ["1310525", "1310533"], "spl_set_id": ["f9c95ed7-130f-9455-e053-6394a90a182f"], "pharm_class_epc": ["Pyrimidine Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (42291-831-30)", "package_ndc": "42291-831-30", "marketing_start_date": "20230420"}], "brand_name": "Teriflunomide", "product_id": "42291-831_4875c75e-d6b3-05a5-e063-6394a90aa62f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]", "Pyrimidine Synthesis Inhibitor [EPC]"], "product_ndc": "42291-831", "generic_name": "Teriflunomide", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Teriflunomide", "active_ingredients": [{"name": "TERIFLUNOMIDE", "strength": "14 mg/1"}], "application_number": "ANDA209700", "marketing_category": "ANDA", "marketing_start_date": "20230420", "listing_expiration_date": "20271231"}