teriflunomide

Generic: teriflunomide

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

teriflunomide 7 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-313
Product ID 46708-313_5c2a05ed-ff36-4dce-97e9-77b2d948b4f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209572
Listing Expiration 2026-12-31
Marketing Start 2023-01-25

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 46708313
Hyphenated Format 46708-313

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 ANDA209572 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (46708-313-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (46708-313-30)
source: ndc

Packages (2)

46708-313-14 2 BLISTER PACK in 1 CARTON (46708-313-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK 46708-313-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-313-30)

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": "5c2a05ed-ff36-4dce-97e9-77b2d948b4f0", "openfda": {"nui": ["N0000185502", "N0000185501"], "unii": ["1C058IKG3B"], "rxcui": ["1310525", "1310533"], "spl_set_id": ["2b084b44-f15b-4b16-b700-4382434f2136"], "pharm_class_epc": ["Pyrimidine Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (46708-313-14)  / 14 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "46708-313-14", "marketing_start_date": "20230125"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (46708-313-30)", "package_ndc": "46708-313-30", "marketing_start_date": "20230125"}], "brand_name": "TERIFLUNOMIDE", "product_id": "46708-313_5c2a05ed-ff36-4dce-97e9-77b2d948b4f0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]", "Pyrimidine Synthesis Inhibitor [EPC]"], "product_ndc": "46708-313", "generic_name": "TERIFLUNOMIDE", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TERIFLUNOMIDE", "active_ingredients": [{"name": "TERIFLUNOMIDE", "strength": "7 mg/1"}], "application_number": "ANDA209572", "marketing_category": "ANDA", "marketing_start_date": "20230125", "listing_expiration_date": "20261231"}