dimethyl fumarate

Generic: dimethyl fumarate kit

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 kit
Labeler glenmark pharmaceuticals inc., usa
Dosage Form KIT
Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-570
Product ID 68462-570_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 68462570
Hyphenated Format 68462-570

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 kit (source: ndc)
Application Number ANDA210309 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 120 mg
  • 240 mg
source: label
Packaging
  • 1 KIT in 1 KIT (68462-570-78) * 14 CAPSULE in 1 BOTTLE * 46 CAPSULE in 1 BOTTLE
source: ndc

Packages (1)

68462-570-78 1 KIT in 1 KIT (68462-570-78) * 14 CAPSULE in 1 BOTTLE * 46 CAPSULE in 1 BOTTLE

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

DIMETHYL FUMARATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"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": "1 KIT in 1 KIT (68462-570-78)  *  14 CAPSULE in 1 BOTTLE *  46 CAPSULE in 1 BOTTLE", "package_ndc": "68462-570-78", "marketing_start_date": "20201006"}], "brand_name": "DIMETHYL FUMARATE", "product_id": "68462-570_74611591-657b-40e8-8ae1-1e5533a05d97", "dosage_form": "KIT", "product_ndc": "68462-570", "generic_name": "dimethyl fumarate kit", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DIMETHYL FUMARATE", "application_number": "ANDA210309", "marketing_category": "ANDA", "marketing_start_date": "20201006", "listing_expiration_date": "20261231"}