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 CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

dimethyl fumarate 120 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-555
Product ID 67877-555_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 67877555
Hyphenated Format 67877-555

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: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67877-555-10)
  • 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67877-555-14)
  • 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67877-555-33)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67877-555-90)
source: ndc

Packages (4)

67877-555-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67877-555-10) 67877-555-14 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67877-555-14) 67877-555-33 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67877-555-33) 67877-555-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67877-555-90)

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": "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": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67877-555-10)", "package_ndc": "67877-555-10", "marketing_start_date": "20200926"}, {"sample": false, "description": "14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67877-555-14)", "package_ndc": "67877-555-14", "marketing_start_date": "20200926"}, {"sample": false, "description": "10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67877-555-33)", "package_ndc": "67877-555-33", "marketing_start_date": "20200926"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67877-555-90)", "package_ndc": "67877-555-90", "marketing_start_date": "20200926"}], "brand_name": "Dimethyl fumarate", "product_id": "67877-555_75f80267-a5b2-4117-8003-05da3e461217", "dosage_form": "CAPSULE, DELAYED RELEASE", "product_ndc": "67877-555", "generic_name": "Dimethyl fumarate", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dimethyl fumarate", "active_ingredients": [{"name": "DIMETHYL FUMARATE", "strength": "120 mg/1"}], "application_number": "ANDA210440", "marketing_category": "ANDA", "marketing_start_date": "20200926", "listing_expiration_date": "20261231"}