FDA.reportPublic FDA data

Mycophenolate Mofetil

Product NDC
0054-0166
11-digit product format
000540166
Labeler code
0054
Product ID
0054-0166_d938a1b7-eed3-4e23-bfef-f88c443d9267
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolate Mofetil
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065413
Marketing category
ANDA
Marketing start
2008-07-29
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
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
0054-0166-25Mycophenolate Mofetil100 in 1 BOTTLETABLET10021
0054-0166-29Mycophenolate Mofetil500 in 1 BOTTLETABLET50021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0166-25EA - Each0054-0166cb1934d9-a3c6-4a11-a394-2788d34cebe912012-07-24
0054-0166-29EA - Each0054-0166e258b4f9-4a04-4153-99b7-ea6e0115dea812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MYCOPHENOLATE MOFETILACTIVE INGREDIENT9242ECW6R0MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC]10
MYCOPHENOLIC ACIDACTIVE MOIETYHU9DX48N0TMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC]10
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC]10
GELATININACTIVE INGREDIENT2G86QN327LMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC]10
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC]10
POVIDONESINACTIVE INGREDIENTFZ989GH94EMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC]10
TRIACETININACTIVE INGREDIENTXHX3C3X673MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0166MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [HIKMA PHARMACEUTICALS USA INC.]20Current NDC, Legacy NDC, 2 package rows20220924_e94895d9-f040-4a75-9f04-9814238b8f3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199058mycophenolate mofetil 250 MG Oral CapsulePSNe94895d9-f040-4a75-9f04-9814238b8f3c21
200060mycophenolate mofetil 500 MG Oral TabletPSNe94895d9-f040-4a75-9f04-9814238b8f3c21
199058mycophenolate mofetil 250 MG Oral CapsuleSCDe94895d9-f040-4a75-9f04-9814238b8f3c21
200060mycophenolate mofetil 500 MG Oral TabletSCDe94895d9-f040-4a75-9f04-9814238b8f3c21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0166-2500054016625100 TABLET in 1 BOTTLE (0054-0166-25) 100 tablet2008-07-290000-00-00NoNoCurrent
0054-0166-2900054016629500 TABLET in 1 BOTTLE (0054-0166-29) 500 tablet2008-07-290000-00-00NoNoCurrent