teriflunomide

Generic: teriflunomide

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

Drug Facts

Product Profile

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

teriflunomide 7 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-246
Product ID 31722-246_f6fdd0c0-59de-107a-e053-6394a90a097d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209598
Listing Expiration 2026-12-31
Marketing Start 2023-03-13

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 31722246
Hyphenated Format 31722-246

Supplemental Identifiers

RxCUI
1310525 1310533
UPC
0331722247306 0331722246309
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 ANDA209598 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (31722-246-30)
source: ndc

Packages (1)

31722-246-30 30 TABLET, FILM COATED in 1 BOTTLE (31722-246-30)

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": "f6fdd0c0-59de-107a-e053-6394a90a097d", "openfda": {"nui": ["N0000185502", "N0000185501"], "upc": ["0331722247306", "0331722246309"], "unii": ["1C058IKG3B"], "rxcui": ["1310525", "1310533"], "spl_set_id": ["9b25c24e-a4a9-43b4-a33f-75bef3a96d5f"], "pharm_class_epc": ["Pyrimidine Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (31722-246-30)", "package_ndc": "31722-246-30", "marketing_start_date": "20230313"}], "brand_name": "Teriflunomide", "product_id": "31722-246_f6fdd0c0-59de-107a-e053-6394a90a097d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]", "Pyrimidine Synthesis Inhibitor [EPC]"], "product_ndc": "31722-246", "generic_name": "Teriflunomide", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Teriflunomide", "active_ingredients": [{"name": "TERIFLUNOMIDE", "strength": "7 mg/1"}], "application_number": "ANDA209598", "marketing_category": "ANDA", "marketing_start_date": "20230313", "listing_expiration_date": "20261231"}