teriflunomide

Generic: teriflunomide

Labeler: natco pharma usa llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name teriflunomide
Generic Name teriflunomide
Labeler natco pharma usa llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

teriflunomide 14 mg/1

Manufacturer
Natco Pharma USA LLC

Identifiers & Regulatory

Product NDC 69339-170
Product ID 69339-170_70bc9344-abbf-4aca-96c0-7f10cfe9aae4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209555
Listing Expiration 2026-12-31
Marketing Start 2023-06-17

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 69339170
Hyphenated Format 69339-170

Supplemental Identifiers

RxCUI
1310525 1310533
UPC
0369339170090 0369339169032 0369339169094
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 ANDA209555 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 14 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (69339-170-03)
  • 90 TABLET in 1 BOTTLE (69339-170-09)
  • 2 BLISTER PACK in 1 CARTON (69339-170-93) / 30 TABLET in 1 BLISTER PACK
source: ndc

Packages (3)

69339-170-03 30 TABLET in 1 BOTTLE (69339-170-03) 69339-170-09 90 TABLET in 1 BOTTLE (69339-170-09) 69339-170-93 2 BLISTER PACK in 1 CARTON (69339-170-93) / 30 TABLET 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": "70bc9344-abbf-4aca-96c0-7f10cfe9aae4", "openfda": {"nui": ["N0000185502", "N0000185501"], "upc": ["0369339170090", "0369339169032", "0369339169094"], "unii": ["1C058IKG3B"], "rxcui": ["1310525", "1310533"], "spl_set_id": ["8219b4a2-fb9d-4387-ba33-96d28aad71dd"], "pharm_class_epc": ["Pyrimidine Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]"], "manufacturer_name": ["Natco Pharma USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (69339-170-03)", "package_ndc": "69339-170-03", "marketing_start_date": "20240102"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (69339-170-09)", "package_ndc": "69339-170-09", "marketing_start_date": "20240102"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (69339-170-93)  / 30 TABLET in 1 BLISTER PACK", "package_ndc": "69339-170-93", "marketing_start_date": "20230617"}], "brand_name": "Teriflunomide", "product_id": "69339-170_70bc9344-abbf-4aca-96c0-7f10cfe9aae4", "dosage_form": "TABLET", "pharm_class": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]", "Pyrimidine Synthesis Inhibitor [EPC]"], "product_ndc": "69339-170", "generic_name": "Teriflunomide", "labeler_name": "Natco Pharma USA LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Teriflunomide", "active_ingredients": [{"name": "TERIFLUNOMIDE", "strength": "14 mg/1"}], "application_number": "ANDA209555", "marketing_category": "ANDA", "marketing_start_date": "20230617", "listing_expiration_date": "20261231"}