dimethyl fumarate

Generic: dimethyl fumarate

Labeler: sola pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

dimethyl fumarate 240 mg/1

Manufacturer
SOLA Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70512-853
Product ID 70512-853_457243f3-2d22-3222-e063-6394a90ae21e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210436
Listing Expiration 2026-12-31
Marketing Start 2023-01-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70512853
Hyphenated Format 70512-853

Supplemental Identifiers

RxCUI
1373483 1373491
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 ANDA210436 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 240 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70512-853-60) / 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (1)

70512-853-60 1 BOTTLE in 1 CARTON (70512-853-60) / 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE

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": "457243f3-2d22-3222-e063-6394a90ae21e", "openfda": {"unii": ["FO2303MNI2"], "rxcui": ["1373483", "1373491"], "spl_set_id": ["b4a200c1-f25a-4aa8-8770-06182fdeda9d"], "manufacturer_name": ["SOLA Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70512-853-60)  / 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "70512-853-60", "marketing_start_date": "20230312"}], "brand_name": "Dimethyl Fumarate", "product_id": "70512-853_457243f3-2d22-3222-e063-6394a90ae21e", "dosage_form": "CAPSULE, DELAYED RELEASE", "product_ndc": "70512-853", "generic_name": "Dimethyl Fumarate", "labeler_name": "SOLA Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dimethyl Fumarate", "active_ingredients": [{"name": "DIMETHYL FUMARATE", "strength": "240 mg/1"}], "application_number": "ANDA210436", "marketing_category": "ANDA", "marketing_start_date": "20230131", "listing_expiration_date": "20261231"}