Dimethyl fumarate

Product NDC
71348-101
11-digit product format
713480101
Labeler code
71348
Product ID
71348-101_a965d490-0d3b-42aa-9c4b-8c356ca208e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dimethyl fumarate
Dosage form
CAPSULE
Route
ORAL
Labeler
PHARMATHEN INTERNATIONAL S.A.
Application
ANDA210436
Marketing category
ANDA
Marketing start
2021-08-01
Marketing end
0000-00-00
Substance
DIMETHYL FUMARATE
Active strength
240 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71348-101-602023-02-15C16284748780-1f386c64a-0c85-0266-e053-dadaa90a7c1aac166df2-d9d0-44eb-a983-a43ba817f9e1
71348-101-602023-01-30C16284748780-1f386c64a-0c85-0266-e053-dadaa90a7c1aac166df2-d9d0-44eb-a983-a43ba817f9e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71348-101-60713480101601 BOTTLE, PLASTIC in 1 CARTON (71348-101-60) > 60 CAPSULE in 1 BOTTLE, PLASTIC2021-08-010000-00-00NoNoCurrent