FDA.reportPublic FDA data

Mycophenolate Mofetil

Product NDC
60429-070
11-digit product format
604290070
Labeler code
60429
Product ID
60429-070_eb6968a1-7970-3caa-e053-2995a90ae6af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mycophenolate mofetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA065521
Marketing category
ANDA
Marketing start
2009-05-04
Marketing end
0000-00-00
Substance
MYCOPHENOLATE MOFETIL
Active strength
500 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
267b34ba-ace4-4048-9f21-d3c7ac983fc3Product name920210224

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-070-01EA - Each60429-07013420d63-ac4e-4815-8000-bf685b49a6ee12015-05-05
60429-070-05EA - Each60429-070f1273c18-2cfe-4b6d-b270-a9edbc10583812015-05-05

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-070MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]11Legacy NDC20240724_1546c504-adfb-453c-a682-8e41888e8b4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200060mycophenolate mofetil 500 MG Oral TabletPSN721564bc-7c0b-4418-ab49-0af362e74eb72
200060mycophenolate mofetil 500 MG Oral TabletSCD721564bc-7c0b-4418-ab49-0af362e74eb72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-070-0160429007001100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60429-070-01) 2015-01-060000-00-00NoNoCurrent
60429-070-0560429007005500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60429-070-05) 2015-01-060000-00-00NoNoCurrent