FDA.reportPublic FDA data

Mycophenolate Mofetil

Product NDC
0378-2250
11-digit product format
003782250
Labeler code
0378
Product ID
0378-2250_6731052a-6bc8-443f-a500-485fe06ea822
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mycophenolate mofetil
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA065520
Marketing category
ANDA
Marketing start
2009-05-04
Marketing end
0000-00-00
Substance
MYCOPHENOLATE MOFETIL
Active strength
250 mg/1
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
267b34ba-ace4-4048-9f21-d3c7ac983fc3Product name920210224
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-2250-01Mycophenolate Mofetil100 in 1 BOTTLE, PLASTICCAPSULE10020
0378-2250-05Mycophenolate Mofetil500 in 1 BOTTLE, PLASTICCAPSULE50020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-2250-01EA - Each0378-2250068aa34f-2b19-413c-81f7-b4373154201c12012-07-24
0378-2250-05EA - Each0378-2250c4107a23-ca92-4cc9-a2fd-18cdd1d4f4cd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MYCOPHENOLATE MOFETILACTIVE INGREDIENT9242ECW6R0MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
MYCOPHENOLIC ACIDACTIVE MOIETYHU9DX48N0TMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
AMMONIAINACTIVE INGREDIENT5138Q19F1XMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
GELATININACTIVE INGREDIENT2G86QN327LMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
POVIDONESINACTIVE INGREDIENTFZ989GH94EMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
SHELLACINACTIVE INGREDIENT46N107B71OMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-2250MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]17Legacy NDC, 2 package rows20250216_74c3a01e-9451-0f2f-6aab-8348047cb1f5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-2250-0100378225001100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2250-01) 100 capsule2009-05-040000-00-00NoNoCurrent
0378-2250-0500378225005500 CAPSULE in 1 BOTTLE, PLASTIC (0378-2250-05) 500 capsule2009-05-040000-00-00NoNoCurrent