teriflunomide

Generic: teriflunomide

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name teriflunomide
Generic Name teriflunomide
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

teriflunomide 7 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-423
Product ID 68462-423_132cc16e-90be-48ac-86a8-deefc187c969
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209663
Listing Expiration 2027-12-31
Marketing Start 2023-01-19

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 68462423
Hyphenated Format 68462-423

Supplemental Identifiers

RxCUI
1310525 1310533
UPC
0368462423301 0368462424308
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 ANDA209663 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (68462-423-15) / 14 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (68462-423-30)
  • 1 BLISTER PACK in 1 CARTON (68462-423-85) / 5 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (3)

68462-423-15 2 BLISTER PACK in 1 CARTON (68462-423-15) / 14 TABLET, FILM COATED in 1 BLISTER PACK 68462-423-30 30 TABLET, FILM COATED in 1 BOTTLE (68462-423-30) 68462-423-85 1 BLISTER PACK in 1 CARTON (68462-423-85) / 5 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": "132cc16e-90be-48ac-86a8-deefc187c969", "openfda": {"nui": ["N0000185502", "N0000185501"], "upc": ["0368462423301", "0368462424308"], "unii": ["1C058IKG3B"], "rxcui": ["1310525", "1310533"], "spl_set_id": ["cb431ea0-ba0f-4b5d-a50d-f8c050762242"], "pharm_class_epc": ["Pyrimidine Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (68462-423-15)  / 14 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "68462-423-15", "marketing_start_date": "20230119"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68462-423-30)", "package_ndc": "68462-423-30", "marketing_start_date": "20230119"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68462-423-85)  / 5 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "68462-423-85", "marketing_start_date": "20230119"}], "brand_name": "teriflunomide", "product_id": "68462-423_132cc16e-90be-48ac-86a8-deefc187c969", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]", "Pyrimidine Synthesis Inhibitor [EPC]"], "product_ndc": "68462-423", "generic_name": "teriflunomide", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "teriflunomide", "active_ingredients": [{"name": "TERIFLUNOMIDE", "strength": "7 mg/1"}], "application_number": "ANDA209663", "marketing_category": "ANDA", "marketing_start_date": "20230119", "listing_expiration_date": "20271231"}