DIMETHYL FUMARATE

Product NDC
68180-776
11-digit product format
681800776
Labeler code
68180
Product ID
68180-776_67133748-3aba-4c65-99de-aede9ab4118e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIMETHYL FUMARATE
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA210226
Marketing category
ANDA
Marketing start
2020-10-31
Marketing end
0000-00-00
Substance
DIMETHYL FUMARATE
Active strength
120 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
782c9b32-f61c-48d7-9845-328403da8b33Product name520250303
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
81073386-7d67-4d1d-80dd-72b360506a77Product name120200414

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-776-14DIMETHYL FUMARATE14 in 1 BOTTLECAPSULE, DELAYED RELEASE146
68180-776-14DIMETHYL FUMARATE1 in 1 CARTONCAPSULE, DELAYED RELEASE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-776DIMETHYL FUMARATE ( DIMETHYL FUMARATE ) KIT DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]6Legacy NDC, 2 package rows20211203_1a70cedb-d909-4d2a-8ab8-07d50a4609a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373497{14 (dimethyl fumarate 120 MG Delayed Release Oral Capsule) / 46 (dimethyl fumarate 240 MG Delayed Release Oral Capsule) } PackGPCK1a70cedb-d909-4d2a-8ab8-07d50a4609a46
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsulePSN1a70cedb-d909-4d2a-8ab8-07d50a4609a46
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsulePSN1a70cedb-d909-4d2a-8ab8-07d50a4609a46
1373497dimethyl fumarate starter dose 120 MG (14), 240 MG (46) Delayed Release Oral Capsule 60 Count PackPSN1a70cedb-d909-4d2a-8ab8-07d50a4609a46
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsuleSCD1a70cedb-d909-4d2a-8ab8-07d50a4609a46
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsuleSCD1a70cedb-d909-4d2a-8ab8-07d50a4609a46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-776-14681800776141 BOTTLE in 1 CARTON (68180-776-14) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2020-10-310000-00-00NoNoCurrent