FDA.reportPublic FDA data

mycophenolate mofetil

Product NDC
67877-266
11-digit product format
678770266
Labeler code
67877
Product ID
67877-266_f8b5a092-55fd-4e91-aa56-98fe69f1c091
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mycophenolate mofetil
Dosage form
CAPSULE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA200197
Marketing category
ANDA
Marketing start
2010-01-01
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
67877-266-01mycophenolate mofetil100 in 1 BOTTLECAPSULE10036
67877-266-05mycophenolate mofetil500 in 1 BOTTLECAPSULE50036
67877-266-38mycophenolate mofetil10 in 1 CARTONCAPSULE1036
67877-266-38mycophenolate mofetil10 in 1 BLISTER PACKCAPSULE1036
67877-266-84mycophenolate mofetil10 in 1 BLISTER PACKCAPSULE1036
67877-266-84mycophenolate mofetil3 in 1 CARTONCAPSULE336

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-266-01EA - Each67877-2664ef1ea12-4a05-4eb3-9eb3-e2378270d00412013-10-17
67877-266-05EA - Each67877-266e80f4cc4-53b7-4169-9841-ecf6c1867e1112013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MYCOPHENOLATE MOFETILACTIVE INGREDIENT9242ECW6R0MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC]15
MYCOPHENOLIC ACIDACTIVE MOIETYHU9DX48N0TMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC]15
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC]15
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC]15
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC]15
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC]15
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC]15
GELATININACTIVE INGREDIENT2G86QN327LMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC]15
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC]15
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC]15
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC]15
POVIDONEINACTIVE INGREDIENTFZ989GH94EMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC]15
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC]15
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC]15
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-266MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC]33Current NDC, Legacy NDC, 6 package rows20240823_9f84ea84-2d8b-4d91-a33f-7dfb5df937dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199058mycophenolate mofetil 250 MG Oral CapsulePSN9f84ea84-2d8b-4d91-a33f-7dfb5df937dc36
200060mycophenolate mofetil 500 MG Oral TabletPSN9f84ea84-2d8b-4d91-a33f-7dfb5df937dc36
199058mycophenolate mofetil 250 MG Oral CapsuleSCD9f84ea84-2d8b-4d91-a33f-7dfb5df937dc36
200060mycophenolate mofetil 500 MG Oral TabletSCD9f84ea84-2d8b-4d91-a33f-7dfb5df937dc36
199058mycophenolate mofetil 250 MG Oral CapsulePSN6abc5727-ee8e-43ad-ab39-0eef2feb257a2
199058mycophenolate mofetil 250 MG Oral CapsulePSN75a76397-bb62-4014-8488-949a711b25f02
199058mycophenolate mofetil 250 MG Oral CapsulePSNfbbe6521-0e21-5372-e053-6394a90ae5e42
200060mycophenolate mofetil 500 MG Oral TabletPSNfbbe6521-0e21-5372-e053-6394a90ae5e42
199058mycophenolate mofetil 250 MG Oral CapsuleSCD6abc5727-ee8e-43ad-ab39-0eef2feb257a2
199058mycophenolate mofetil 250 MG Oral CapsuleSCD75a76397-bb62-4014-8488-949a711b25f02
199058mycophenolate mofetil 250 MG Oral CapsuleSCDfbbe6521-0e21-5372-e053-6394a90ae5e42
200060mycophenolate mofetil 500 MG Oral TabletSCDfbbe6521-0e21-5372-e053-6394a90ae5e42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-266-0167877026601100 CAPSULE in 1 BOTTLE (67877-266-01) 100 capsule2010-01-010000-00-00NoNoCurrent
67877-266-0567877026605500 CAPSULE in 1 BOTTLE (67877-266-05) 500 capsule2010-01-010000-00-00NoNoCurrent
67877-266-386787702663810 BLISTER PACK in 1 CARTON (67877-266-38) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2010-01-010000-00-00NoNoCurrent
67877-266-84678770266843 BLISTER PACK in 1 CARTON (67877-266-84) / 10 CAPSULE in 1 BLISTER PACK3 blister pack2010-01-010000-00-00NoNoCurrent