FDA.reportPublic FDA data

Mycophenolate Mofetil

Product NDC
50090-4275
11-digit product format
500904275
Labeler code
50090
Product ID
50090-4275_bb6d7460-3900-4940-8564-af7078969144
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolate Mofetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091249
Marketing category
ANDA
Marketing start
2011-11-28
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4275-02023-02-07C16284748780-1f386c649-e05b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL TABLETS and MYCOPHENOLATE MOFETIL CAPSULES safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL TABLETS and MYCOPHENOLATE MOFETIL CAPSULES MYCOPHENOLATE MOFETIL tablets, for oral use MYCOPHENOLATE MOFETIL capsules, for oral use Initial U.S. Approval: 1995
50090-4275-02023-01-30C16284748780-1f386c649-e05b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL TABLETS and MYCOPHENOLATE MOFETIL CAPSULES safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL TABLETS and MYCOPHENOLATE MOFETIL CAPSULES MYCOPHENOLATE MOFETIL tablets, for oral use MYCOPHENOLATE MOFETIL capsules, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4275-0Mycophenolate Mofetil180 in 1 BOTTLETABLET, FILM COATED18013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4275-0EA - Each50090-4275d1e2d60e-e756-4a20-b5e1-a7fd1cf8f06412022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4275MYCOPHENOLATE MOFETIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 1 package rows20240511_b4170ad9-67f0-42ea-b694-6b80824a607a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200060mycophenolate mofetil 500 MG Oral TabletPSNb4170ad9-67f0-42ea-b694-6b80824a607a13
200060mycophenolate mofetil 500 MG Oral TabletSCDb4170ad9-67f0-42ea-b694-6b80824a607a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4275-050090427500180 TABLET, FILM COATED in 1 BOTTLE (50090-4275-0) 2019-04-190000-00-00NoNoCurrent