teriflunomide

Generic: teriflunomide

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name teriflunomide
Generic Name teriflunomide
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

teriflunomide 7 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-054
Product ID 59651-054_d9e4b485-c320-432e-8558-8975f969000e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209638
Listing Expiration 2026-12-31
Marketing Start 2023-02-28

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 59651054
Hyphenated Format 59651-054

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 ANDA209638 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (59651-054-28) / 14 TABLET in 1 BLISTER PACK
  • 30 TABLET in 1 BOTTLE (59651-054-30)
source: ndc

Packages (2)

59651-054-28 2 BLISTER PACK in 1 CARTON (59651-054-28) / 14 TABLET in 1 BLISTER PACK 59651-054-30 30 TABLET in 1 BOTTLE (59651-054-30)

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": "d9e4b485-c320-432e-8558-8975f969000e", "openfda": {"nui": ["N0000185502", "N0000185501"], "unii": ["1C058IKG3B"], "rxcui": ["1310525", "1310533"], "spl_set_id": ["2fd80242-c607-4c50-b497-8259abb4a2f8"], "pharm_class_epc": ["Pyrimidine Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (59651-054-28)  / 14 TABLET in 1 BLISTER PACK", "package_ndc": "59651-054-28", "marketing_start_date": "20230228"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (59651-054-30)", "package_ndc": "59651-054-30", "marketing_start_date": "20230228"}], "brand_name": "Teriflunomide", "product_id": "59651-054_d9e4b485-c320-432e-8558-8975f969000e", "dosage_form": "TABLET", "pharm_class": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]", "Pyrimidine Synthesis Inhibitor [EPC]"], "product_ndc": "59651-054", "generic_name": "Teriflunomide", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Teriflunomide", "active_ingredients": [{"name": "TERIFLUNOMIDE", "strength": "7 mg/1"}], "application_number": "ANDA209638", "marketing_category": "ANDA", "marketing_start_date": "20230228", "listing_expiration_date": "20261231"}