FDA.reportPublic FDA data

Mycophenolate mofetil

Product NDC
73190-009
11-digit product format
731900009
Labeler code
73190
Product ID
73190-009_339a10d4-599c-e16c-e063-6294a90aa2a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolate mofetil
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA090055
Marketing category
ANDA
Marketing start
2025-04-25
Substance
MYCOPHENOLATE MOFETIL
Active strength
250 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 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
73190-009-01Mycophenolate mofetil100 in 1 BOTTLECAPSULE1001
73190-009-50Mycophenolate mofetil500 in 1 BOTTLECAPSULE5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73190-009-01EA - Each73190-009770729c8-db62-4de9-97df-96b4e535180312025-06-13
73190-009-50EA - Each73190-009393a2801-9536-442f-b9a2-0065ec2534f312025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73190-009MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [AVKARE]1Current NDC, 2 package rows20250427_339a10c4-e442-de9e-e063-6294a90a6208.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199058mycophenolate mofetil 250 MG Oral CapsulePSN339a10c4-e442-de9e-e063-6294a90a62081
200060mycophenolate mofetil 500 MG Oral TabletPSN339a10c4-e442-de9e-e063-6294a90a62081
199058mycophenolate mofetil 250 MG Oral CapsuleSCD339a10c4-e442-de9e-e063-6294a90a62081
200060mycophenolate mofetil 500 MG Oral TabletSCD339a10c4-e442-de9e-e063-6294a90a62081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73190-009-0173190000901100 CAPSULE in 1 BOTTLE (73190-009-01) 100 capsule2025-04-25NoNoCurrent
73190-009-5073190000950500 CAPSULE in 1 BOTTLE (73190-009-50) 500 capsule2025-04-25NoNoCurrent