dimethyl fumarate

Generic: dimethyl fumarate

Labeler: dr. reddy's laboratories inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dimethyl fumarate
Generic Name dimethyl fumarate
Labeler dr. reddy's laboratories inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

dimethyl fumarate 240 mg/1

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-430
Product ID 43598-430_fcfea8cf-7720-664c-345c-b8baeff438ee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210460
Listing Expiration 2026-12-31
Marketing Start 2020-09-25

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598430
Hyphenated Format 43598-430

Supplemental Identifiers

RxCUI
1373483 1373491
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 ANDA210460 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 240 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (43598-430-60) / 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (1)

43598-430-60 1 BOTTLE in 1 CARTON (43598-430-60) / 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Ingredients (1)

dimethyl fumarate (240 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": "fcfea8cf-7720-664c-345c-b8baeff438ee", "openfda": {"unii": ["FO2303MNI2"], "rxcui": ["1373483", "1373491"], "spl_set_id": ["b00dcf89-59d3-9ab2-fd9b-16b9ec2d677b"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (43598-430-60)  / 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "43598-430-60", "marketing_start_date": "20200925"}], "brand_name": "Dimethyl Fumarate", "product_id": "43598-430_fcfea8cf-7720-664c-345c-b8baeff438ee", "dosage_form": "CAPSULE, DELAYED RELEASE", "product_ndc": "43598-430", "generic_name": "Dimethyl fumarate", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dimethyl Fumarate", "active_ingredients": [{"name": "DIMETHYL FUMARATE", "strength": "240 mg/1"}], "application_number": "ANDA210460", "marketing_category": "ANDA", "marketing_start_date": "20200925", "listing_expiration_date": "20261231"}