FDA.reportPublic FDA data

mycophenolate mofetil

Product NDC
50268-557
11-digit product format
502680557
Labeler code
50268
Product ID
50268-557_47e7bafd-1b50-c454-e063-6394a90a6868
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mycophenolate mofetil
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA200197
Marketing category
ANDA
Marketing start
2023-05-15
Substance
MYCOPHENOLATE MOFETIL
Active strength
250 mg/1
Pharmacologic classes
Antimetabolite Immunosuppressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
mycophenolate mofetil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MYCOPHENOLATE MOFETIL250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9242ECW6R0
Rxcui199058, 200060

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-557-11mycophenolate mofetil1 in 1 BLISTER PACKCAPSULE12
50268-557-15mycophenolate mofetil50 in 1 BOXCAPSULE502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-557-11EA - Each50268-5574526d08d-b084-4f49-a71f-09520d0fb3b012023-06-06
50268-557-15EA - Each50268-557880c5008-563d-450f-84ab-3196e2f16c3112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-557MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [AVPAK]1Current NDC, 2 package rows20230517_fbbe6521-0e21-5372-e053-6394a90ae5e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199058mycophenolate mofetil 250 MG Oral CapsulePSNfbbe6521-0e21-5372-e053-6394a90ae5e42
200060mycophenolate mofetil 500 MG Oral TabletPSNfbbe6521-0e21-5372-e053-6394a90ae5e42
199058mycophenolate mofetil 250 MG Oral CapsuleSCDfbbe6521-0e21-5372-e053-6394a90ae5e42
200060mycophenolate mofetil 500 MG Oral TabletSCDfbbe6521-0e21-5372-e053-6394a90ae5e42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50268-557-11502680557111 in 1 BLISTER PACKHistorical
50268-557-155026805571550 BLISTER PACK in 1 BOX (50268-557-15) / 1 CAPSULE in 1 BLISTER PACK (50268-557-11) 50 blister pack2023-05-15NoNoHistorical