DIMETHYL FUMARATE

Product NDC
31722-680
11-digit product format
317220680
Labeler code
31722
Product ID
31722-680_1814ba82-76cc-c580-e063-6294a90a5e57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dimethyl fumarate
Dosage form
KIT
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA210500
Marketing category
ANDA
Marketing start
2020-09-24
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DIMETHYL FUMARATE
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFO2303MNI2
Rxcui1373483, 1373491, 1373497

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
782c9b32-f61c-48d7-9845-328403da8b33Product name520250303
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
81073386-7d67-4d1d-80dd-72b360506a77Product name120200414
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-680-60DIMETHYL FUMARATE1 in 1 KITKIT17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-680DIMETHYL FUMARATE (DIMETHYL FUMARATE) CAPSULE, DELAYED RELEASE DIMETHYL FUMARATE KIT [CAMBER PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 1 package rows20240511_b856ac70-71cd-477b-95b1-0a6132c260e8.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) } PackGPCKb856ac70-71cd-477b-95b1-0a6132c260e87
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsulePSNb856ac70-71cd-477b-95b1-0a6132c260e87
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsulePSNb856ac70-71cd-477b-95b1-0a6132c260e87
1373497dimethyl fumarate starter dose 120 MG (14), 240 MG (46) Delayed Release Oral Capsule 60 Count PackPSNb856ac70-71cd-477b-95b1-0a6132c260e87
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsuleSCDb856ac70-71cd-477b-95b1-0a6132c260e87
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsuleSCDb856ac70-71cd-477b-95b1-0a6132c260e87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-680-60317220680601 KIT in 1 KIT (31722-680-60) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 kit2020-09-240000-00-00NoNoCurrent