dimethyl fumarate

Generic: dimethyl-fumarate

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

Drug Facts

Product Profile

Brand Name dimethyl fumarate
Generic Name dimethyl-fumarate
Labeler glenmark pharmaceuticals inc., usa
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dimethyl fumarate 120 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-307
Product ID 68462-307_74611591-657b-40e8-8ae1-1e5533a05d97
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210309
Listing Expiration 2026-12-31
Marketing Start 2020-10-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462307
Hyphenated Format 68462-307

Supplemental Identifiers

RxCUI
1373483 1373491 1373497
UNII
FO2303MNI2

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 dimethyl fumarate (source: ndc)
Generic Name dimethyl-fumarate (source: ndc)
Application Number ANDA210309 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (68462-307-05)
  • 14 CAPSULE in 1 BOTTLE (68462-307-41)
source: ndc

Packages (2)

68462-307-05 500 CAPSULE in 1 BOTTLE (68462-307-05) 68462-307-41 14 CAPSULE in 1 BOTTLE (68462-307-41)

Ingredients (1)

dimethyl fumarate (120 mg/1)

Linked Drug Pages (1)

DIMETHYL FUMARATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "74611591-657b-40e8-8ae1-1e5533a05d97", "openfda": {"unii": ["FO2303MNI2"], "rxcui": ["1373483", "1373491", "1373497"], "spl_set_id": ["c3f65da9-f5f4-4161-aded-c23b16fd49ed"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE (68462-307-05)", "package_ndc": "68462-307-05", "marketing_start_date": "20201006"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (68462-307-41)", "package_ndc": "68462-307-41", "marketing_start_date": "20201006"}], "brand_name": "DIMETHYL FUMARATE", "product_id": "68462-307_74611591-657b-40e8-8ae1-1e5533a05d97", "dosage_form": "CAPSULE", "product_ndc": "68462-307", "generic_name": "dimethyl-fumarate", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DIMETHYL FUMARATE", "active_ingredients": [{"name": "DIMETHYL FUMARATE", "strength": "120 mg/1"}], "application_number": "ANDA210309", "marketing_category": "ANDA", "marketing_start_date": "20201006", "listing_expiration_date": "20261231"}