dimethyl fumarate

Generic: dimethyl fumarate

Labeler: msn laboratories private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dimethyl fumarate
Generic Name dimethyl fumarate
Labeler msn laboratories private limited
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

dimethyl fumarate 120 mg/1

Manufacturer
MSN LABORATORIES PRIVATE LIMITED

Identifiers & Regulatory

Product NDC 69539-042
Product ID 69539-042_1e7672d0-2532-401b-81a2-dd76968d2745
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210460
Listing Expiration 2026-12-31
Marketing Start 2020-09-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69539042
Hyphenated Format 69539-042

Supplemental Identifiers

RxCUI
1373483 1373491 1373497
UPC
0369539042555 0369539043460 0369539042050 0369539043057 0369539042616 0369539043606 0369539240180
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 ANDA210460 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (69539-042-05) / 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (69539-042-61) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

69539-042-05 1 BOTTLE in 1 CARTON (69539-042-05) / 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE 69539-042-61 1 BOTTLE in 1 CARTON (69539-042-61) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

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": "1e7672d0-2532-401b-81a2-dd76968d2745", "openfda": {"upc": ["0369539042555", "0369539043460", "0369539042050", "0369539043057", "0369539042616", "0369539043606", "0369539240180"], "unii": ["FO2303MNI2"], "rxcui": ["1373483", "1373491", "1373497"], "spl_set_id": ["074d2820-6cb4-437a-8f6f-a21cb0a8ee02"], "manufacturer_name": ["MSN LABORATORIES PRIVATE LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69539-042-05)  / 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "69539-042-05", "marketing_start_date": "20200928"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69539-042-61)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "69539-042-61", "marketing_start_date": "20200928"}], "brand_name": "Dimethyl Fumarate", "product_id": "69539-042_1e7672d0-2532-401b-81a2-dd76968d2745", "dosage_form": "CAPSULE, DELAYED RELEASE", "product_ndc": "69539-042", "generic_name": "Dimethyl fumarate", "labeler_name": "MSN LABORATORIES PRIVATE LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dimethyl Fumarate", "active_ingredients": [{"name": "DIMETHYL FUMARATE", "strength": "120 mg/1"}], "application_number": "ANDA210460", "marketing_category": "ANDA", "marketing_start_date": "20200928", "listing_expiration_date": "20261231"}