mycophenolate mofetil

Product NDC
70121-1584
11-digit product format
701211584
Labeler code
70121
Product ID
70121-1584_fc919663-569c-496a-ac22-aa14fccd4feb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mycophenolate mofetil
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA211374
Marketing category
ANDA
Marketing start
2021-03-07
Marketing end
0000-00-00
Substance
MYCOPHENOLATE MOFETIL
Active strength
500 mg/20mL
Pharmacologic classes
Antimetabolite Immunosuppressant [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04b26d3d-97dc-48db-824b-10b299945382Product name820250224
1aa45098-03f9-4bf8-b28d-2566aa0f7f4bProduct name120250218
267b34ba-ace4-4048-9f21-d3c7ac983fc3Product name920210224

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1584MYCOPHENOLATE MOFETIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC]11Legacy NDC20230519_47e14e11-b072-410c-8061-e70631b3bfc8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1584-4701211584044 VIAL in 1 CARTON (70121-1584-4) > 20 mL in 1 VIAL (70121-1584-1) 4 vial2021-03-070000-00-00NoNoCurrent