FDA.reportPublic FDA data

Mycophenolate mofetil

Product NDC
64380-726
11-digit product format
643800726
Labeler code
64380
Product ID
64380-726_51752987-c49c-40b6-8fe2-1d1c99554312
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolate mofetil
Dosage form
CAPSULE
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA090055
Marketing category
ANDA
Marketing start
2010-11-06
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
64380-726-06Mycophenolate mofetil100 in 1 BOTTLE, PLASTICCAPSULE10019
64380-726-07Mycophenolate mofetil500 in 1 BOTTLE, PLASTICCAPSULE50019
64380-726-11Mycophenolate mofetil120 in 1 BOTTLE, PLASTICCAPSULE12019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-726-06EA - Each64380-726f1a2cd12-dced-4589-935b-e4aa096487dd12014-02-04
64380-726-07EA - Each64380-7261c18f81b-9c06-4b43-a4c6-f6151b324c4812014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MYCOPHENOLATE MOFETILACTIVE INGREDIENT9242ECW6R0MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED]5
MYCOPHENOLIC ACIDACTIVE MOIETYHU9DX48N0TMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED]5
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED]5
GELATININACTIVE INGREDIENT2G86QN327LMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED]5
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-726MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES PHARMA SCIENCE LIMITED]17Current NDC, Legacy NDC, 3 package rows20250516_32dd890a-cfe3-4129-bce6-1d3dbe38e4f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199058mycophenolate mofetil 250 MG Oral CapsulePSN32dd890a-cfe3-4129-bce6-1d3dbe38e4f319
200060mycophenolate mofetil 500 MG Oral TabletPSN32dd890a-cfe3-4129-bce6-1d3dbe38e4f319
199058mycophenolate mofetil 250 MG Oral CapsuleSCD32dd890a-cfe3-4129-bce6-1d3dbe38e4f319
200060mycophenolate mofetil 500 MG Oral TabletSCD32dd890a-cfe3-4129-bce6-1d3dbe38e4f319

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-726-0664380072606100 CAPSULE in 1 BOTTLE, PLASTIC (64380-726-06) 100 capsule2010-11-060000-00-00NoNoCurrent
64380-726-0764380072607500 CAPSULE in 1 BOTTLE, PLASTIC (64380-726-07) 500 capsule2010-11-060000-00-00NoNoCurrent
64380-726-1164380072611120 CAPSULE in 1 BOTTLE, PLASTIC (64380-726-11) 120 capsule2010-11-060000-00-00NoNoCurrent