teriflunomide

Generic: teriflunomide

Labeler: msn laboratories private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name teriflunomide
Generic Name teriflunomide
Labeler msn laboratories private limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

teriflunomide 14 mg/1

Manufacturer
MSN LABORATORIES PRIVATE LIMITED

Identifiers & Regulatory

Product NDC 69539-316
Product ID 69539-316_3b178225-b3ba-4c9f-bde6-a5e076697980
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209623
Listing Expiration 2026-12-31
Marketing Start 2019-04-24

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 69539316
Hyphenated Format 69539-316

Supplemental Identifiers

RxCUI
1310525 1310533
UPC
0369539033416 0369539033300 0369539032419
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 ANDA209623 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 14 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (69539-316-30)
  • 2 BLISTER PACK in 1 CARTON (69539-316-41) / 14 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

69539-316-30 30 TABLET, FILM COATED in 1 BOTTLE (69539-316-30) 69539-316-41 2 BLISTER PACK in 1 CARTON (69539-316-41) / 14 TABLET, FILM COATED 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": "3b178225-b3ba-4c9f-bde6-a5e076697980", "openfda": {"nui": ["N0000185502", "N0000185501"], "upc": ["0369539033416", "0369539033300", "0369539032419"], "unii": ["1C058IKG3B"], "rxcui": ["1310525", "1310533"], "spl_set_id": ["63ba28ef-5055-461a-99ef-c49e8ece4b54"], "pharm_class_epc": ["Pyrimidine Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]"], "manufacturer_name": ["MSN LABORATORIES PRIVATE LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (69539-316-30)", "package_ndc": "69539-316-30", "marketing_start_date": "20230204"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (69539-316-41)  / 14 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "69539-316-41", "marketing_start_date": "20190424"}], "brand_name": "Teriflunomide", "product_id": "69539-316_3b178225-b3ba-4c9f-bde6-a5e076697980", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]", "Pyrimidine Synthesis Inhibitor [EPC]"], "product_ndc": "69539-316", "generic_name": "Teriflunomide", "labeler_name": "MSN LABORATORIES PRIVATE LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Teriflunomide", "active_ingredients": [{"name": "TERIFLUNOMIDE", "strength": "14 mg/1"}], "application_number": "ANDA209623", "marketing_category": "ANDA", "marketing_start_date": "20190424", "listing_expiration_date": "20261231"}