dimethyl fumarate

Generic: dimethyl fumarate

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dimethyl fumarate
Generic Name dimethyl fumarate
Labeler amneal pharmaceuticals ny llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

dimethyl fumarate 120 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1318
Product ID 69238-1318_76c5e6b0-c799-45cf-adb6-2d3845639b62
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210402
Listing Expiration 2026-12-31
Marketing Start 2020-09-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692381318
Hyphenated Format 69238-1318

Supplemental Identifiers

RxCUI
1373483 1373491 1373497
UPC
0369238131963 0369238162639 0369238162684
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 ANDA210402 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (69238-1318-4) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (1)

69238-1318-4 1 BOTTLE in 1 CARTON (69238-1318-4) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Ingredients (1)

dimethyl fumarate (120 mg/1)

Linked Drug Pages (1)

Dimethyl Fumarate, DIMETHYL FUMARATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "76c5e6b0-c799-45cf-adb6-2d3845639b62", "openfda": {"upc": ["0369238131963", "0369238162639", "0369238162684"], "unii": ["FO2303MNI2"], "rxcui": ["1373483", "1373491", "1373497"], "spl_set_id": ["4c7626c6-2b1b-4865-818c-0c79c18c049d"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69238-1318-4)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "69238-1318-4", "marketing_start_date": "20200928"}], "brand_name": "Dimethyl Fumarate", "product_id": "69238-1318_76c5e6b0-c799-45cf-adb6-2d3845639b62", "dosage_form": "CAPSULE, DELAYED RELEASE", "product_ndc": "69238-1318", "generic_name": "Dimethyl Fumarate", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dimethyl Fumarate", "active_ingredients": [{"name": "DIMETHYL FUMARATE", "strength": "120 mg/1"}], "application_number": "ANDA210402", "marketing_category": "ANDA", "marketing_start_date": "20200928", "listing_expiration_date": "20261231"}