dimethyl fumarate

Generic: dimethyl fumarate

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dimethyl fumarate
Generic Name dimethyl fumarate
Labeler cipla usa inc.
Dosage Form KIT
Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-552
Product ID 69097-552_d64e8be8-de52-40c2-8730-bef67c6b0914
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210305
Listing Expiration 2026-12-31
Marketing Start 2020-09-24

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097552
Hyphenated Format 69097-552

Supplemental Identifiers

RxCUI
1373483 1373491 1373497
UPC
0369097323035 0369097322892 0369097323882 0369097552039
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 ANDA210305 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 120 mg
  • 240 mg
source: label
Packaging
  • 1 KIT in 1 KIT (69097-552-03) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

69097-552-03 1 KIT in 1 KIT (69097-552-03) * 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 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "d64e8be8-de52-40c2-8730-bef67c6b0914", "openfda": {"upc": ["0369097323035", "0369097322892", "0369097323882", "0369097552039"], "unii": ["FO2303MNI2"], "rxcui": ["1373483", "1373491", "1373497"], "spl_set_id": ["6c42107a-2a42-4263-97b6-ae0d7675c92a"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 KIT (69097-552-03)  *  14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC *  46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC", "package_ndc": "69097-552-03", "marketing_start_date": "20200924"}], "brand_name": "DIMETHYL FUMARATE", "product_id": "69097-552_d64e8be8-de52-40c2-8730-bef67c6b0914", "dosage_form": "KIT", "product_ndc": "69097-552", "generic_name": "DIMETHYL FUMARATE", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DIMETHYL FUMARATE", "application_number": "ANDA210305", "marketing_category": "ANDA", "marketing_start_date": "20200924", "listing_expiration_date": "20261231"}