Mycophenolic Acid

Product NDC
60429-016
11-digit product format
604290016
Labeler code
60429
Product ID
60429-016_43d1856e-e3d4-1b7d-e063-6394a90a238f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolic Acid
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA091558
Marketing category
ANDA
Marketing start
2012-08-21
Substance
MYCOPHENOLATE SODIUM
Active strength
180 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
Mycophenolic Acid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MYCOPHENOLATE SODIUM180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWX877SQI1G
Rxcui485020, 485023

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
60429-016-12Mycophenolic Acid120 in 1 BOTTLETABLET, DELAYED RELEASE12013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-016-12EA - Each60429-016f0be9848-a527-4949-8762-d88afc72396612015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MYCOPHENOLATE SODIUMACTIVE INGREDIENTWX877SQI1GMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
mycophenolic acidACTIVE MOIETYHU9DX48N0TMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
METHYLCELLULOSE (400 MPA.S)INACTIVE INGREDIENTO0GN6F9B2YMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-016MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]11Current NDC, Legacy NDC, 1 package rows20241024_3a0a6ef4-fb2c-47be-82d7-d2675059c45b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485020mycophenolic acid 180 MG Delayed Release Oral TabletPSN3a0a6ef4-fb2c-47be-82d7-d2675059c45b13
485023mycophenolic acid 360 MG Delayed Release Oral TabletPSN3a0a6ef4-fb2c-47be-82d7-d2675059c45b13
485020mycophenolic acid 180 MG Delayed Release Oral TabletSCD3a0a6ef4-fb2c-47be-82d7-d2675059c45b13
485023mycophenolic acid 360 MG Delayed Release Oral TabletSCD3a0a6ef4-fb2c-47be-82d7-d2675059c45b13
485020mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral TabletSY3a0a6ef4-fb2c-47be-82d7-d2675059c45b13
485023mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral TabletSY3a0a6ef4-fb2c-47be-82d7-d2675059c45b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-016-1260429001612120 TABLET, DELAYED RELEASE in 1 BOTTLE (60429-016-12) 2014-10-130000-00-00NoNoCurrent