dimethyl fumarate

Generic: dimethyl fumarate

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dimethyl fumarate
Generic Name dimethyl fumarate
Labeler upsher-smith laboratories, llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

dimethyl fumarate 240 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 24979-128
Product ID 24979-128_8b1210a2-c1ad-44b7-8afe-a5c55bfb5be8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210382
Listing Expiration 2027-12-31
Marketing Start 2020-12-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24979128
Hyphenated Format 24979-128

Supplemental Identifiers

RxCUI
1373483 1373491
UPC
0324979127217 0324979128047
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 ANDA210382 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 240 mg/1
source: ndc
Packaging
  • 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (24979-128-02)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (24979-128-04)
source: ndc

Packages (2)

24979-128-02 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (24979-128-02) 24979-128-04 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (24979-128-04)

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": "8b1210a2-c1ad-44b7-8afe-a5c55bfb5be8", "openfda": {"upc": ["0324979127217", "0324979128047"], "unii": ["FO2303MNI2"], "rxcui": ["1373483", "1373491"], "spl_set_id": ["48f56f42-2247-41a9-a1e9-07c3af50e549"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (24979-128-02)", "package_ndc": "24979-128-02", "marketing_start_date": "20201201"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (24979-128-04)", "package_ndc": "24979-128-04", "marketing_start_date": "20201201"}], "brand_name": "dimethyl fumarate", "product_id": "24979-128_8b1210a2-c1ad-44b7-8afe-a5c55bfb5be8", "dosage_form": "CAPSULE, DELAYED RELEASE", "product_ndc": "24979-128", "generic_name": "dimethyl fumarate", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "dimethyl fumarate", "active_ingredients": [{"name": "DIMETHYL FUMARATE", "strength": "240 mg/1"}], "application_number": "ANDA210382", "marketing_category": "ANDA", "marketing_start_date": "20201201", "listing_expiration_date": "20271231"}