Mycophenolate mofetil

Product NDC
55154-3571
11-digit product format
551543571
Labeler code
55154
Product ID
55154-3571_31037fb8-b9c3-40bc-b26a-43caa7560e7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolate mofetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA090456
Marketing category
ANDA
Marketing start
2010-11-06
Substance
MYCOPHENOLATE MOFETIL
Active strength
500 mg/1
Pharmacologic classes
Antimetabolite Immunosuppressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mycophenolate mofetil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MYCOPHENOLATE MOFETIL500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9242ECW6R0
Rxcui200060

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
55154-3571-0Mycophenolate mofetil10 in 1 BAGTABLET, FILM COATED104
55154-3571-0Mycophenolate mofetil1 in 1 BLISTER PACKTABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-3571MYCOPHENOLATE MOFETIL TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]2Current NDC, Legacy NDC, 2 package rows20241025_f2eafcbb-77ab-461e-aa09-9cc4123eb3bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200060mycophenolate mofetil 500 MG Oral TabletPSNf2eafcbb-77ab-461e-aa09-9cc4123eb3bd4
200060mycophenolate mofetil 500 MG Oral TabletSCDf2eafcbb-77ab-461e-aa09-9cc4123eb3bd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-3571-05515435710010 BLISTER PACK in 1 BAG (55154-3571-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2010-11-060000-00-00NoNoCurrent