dimethyl fumarate

Generic: dimethyl fumarate

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dimethyl fumarate
Generic Name dimethyl fumarate
Labeler ascend laboratories, llc
Dosage Form KIT
Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-557
Product ID 67877-557_75f80267-a5b2-4117-8003-05da3e461217
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210440
Listing Expiration 2026-12-31
Marketing Start 2020-09-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877557
Hyphenated Format 67877-557

Supplemental Identifiers

RxCUI
1373483 1373491 1373497
UPC
0367877555324
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 ANDA210440 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 120 mg
  • 240 mg
source: label
Packaging
  • 1 KIT in 1 KIT (67877-557-39) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

67877-557-39 1 KIT in 1 KIT (67877-557-39) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Dimethyl fumarate, Dimethyl Fumarate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "75f80267-a5b2-4117-8003-05da3e461217", "openfda": {"upc": ["0367877555324"], "unii": ["FO2303MNI2"], "rxcui": ["1373483", "1373491", "1373497"], "spl_set_id": ["e12d8fee-bd18-4f84-8333-c890f1d132b7"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 KIT (67877-557-39)  *  14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC *  46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC", "package_ndc": "67877-557-39", "marketing_start_date": "20200926"}], "brand_name": "Dimethyl Fumarate", "product_id": "67877-557_75f80267-a5b2-4117-8003-05da3e461217", "dosage_form": "KIT", "product_ndc": "67877-557", "generic_name": "Dimethyl Fumarate", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dimethyl Fumarate", "application_number": "ANDA210440", "marketing_category": "ANDA", "marketing_start_date": "20200926", "listing_expiration_date": "20261231"}