Mycophenolate Mofetil

Product NDC
0093-7334
11-digit product format
000937334
Labeler code
0093
Product ID
0093-7334_d924ecfe-fba4-41ad-a1c1-e8ee06d76e67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolate Mofetil
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA065491
Marketing category
ANDA
Marketing start
2009-05-06
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

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
0093-7334-01Mycophenolate Mofetil100 in 1 BOTTLECAPSULE10033
0093-7334-05Mycophenolate Mofetil500 in 1 BOTTLECAPSULE50033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7334-01EA - Each0093-7334e0a56add-0951-43c1-a8e7-acbafec30dc312012-07-24
0093-7334-05EA - Each0093-7334f704eb5a-6817-40ca-970b-09204b163fce12012-07-24
0093-7334-19EA - Each0093-73347010a639-d7a3-4da9-8bb5-8deb9e63540312012-07-24
0093-7334-93EA - Each0093-73348fd25444-aa9f-472b-88a7-8e245ee15ef712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MYCOPHENOLATE MOFETILACTIVE INGREDIENT9242ECW6R0MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]15
MYCOPHENOLIC ACIDACTIVE MOIETYHU9DX48N0TMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]15
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]15
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]15
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]15
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]15
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]15
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]15
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]15
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]15
GELATININACTIVE INGREDIENT2G86QN327LMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]15
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]15
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]15
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]15
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]15
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]15
SHELLACINACTIVE INGREDIENT46N107B71OMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]15
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]15
TALCINACTIVE INGREDIENT7SEV7J4R1UMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7334MYCOPHENOLATE MOFETIL CAPSULE [TEVA PHARMACEUTICALS USA, INC.]32Current NDC, Legacy NDC, 2 package rows20250502_b414303f-e6f3-4e22-a537-96be352b59a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199058mycophenolate mofetil 250 MG Oral CapsulePSNb414303f-e6f3-4e22-a537-96be352b59a433
199058mycophenolate mofetil 250 MG Oral CapsuleSCDb414303f-e6f3-4e22-a537-96be352b59a433

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-7334-0100093733401100 CAPSULE in 1 BOTTLE (0093-7334-01) 100 capsule2009-05-060000-00-00NoNoCurrent
0093-7334-0500093733405500 CAPSULE in 1 BOTTLE (0093-7334-05) 500 capsule2009-05-060000-00-00NoNoCurrent