dimethyl fumarate

Generic: dimethyl fumarate

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

Drug Facts

Product Profile

Brand Name dimethyl fumarate
Generic Name dimethyl fumarate
Labeler zydus pharmaceuticals usa inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

dimethyl fumarate 120 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1204
Product ID 70710-1204_548169c7-23fb-46e1-9a8d-556a00ee5cbc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210538
Listing Expiration 2026-12-31
Marketing Start 2020-09-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707101204
Hyphenated Format 70710-1204

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 ANDA210538 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70710-1204-7)
source: ndc

Packages (1)

70710-1204-7 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70710-1204-7)

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": "548169c7-23fb-46e1-9a8d-556a00ee5cbc", "openfda": {"unii": ["FO2303MNI2"], "rxcui": ["1373483", "1373491", "1373497"], "spl_set_id": ["e7ef9b9e-d97a-4a56-b792-a1a255613156"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70710-1204-7)", "package_ndc": "70710-1204-7", "marketing_start_date": "20200928"}], "brand_name": "dimethyl fumarate", "product_id": "70710-1204_548169c7-23fb-46e1-9a8d-556a00ee5cbc", "dosage_form": "CAPSULE, DELAYED RELEASE", "product_ndc": "70710-1204", "generic_name": "dimethyl fumarate", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "dimethyl fumarate", "active_ingredients": [{"name": "DIMETHYL FUMARATE", "strength": "120 mg/1"}], "application_number": "ANDA210538", "marketing_category": "ANDA", "marketing_start_date": "20200928", "listing_expiration_date": "20261231"}