FDA.reportPublic FDA data

MYCOPHENOLIC ACID

Product NDC
0904-7372
11-digit product format
009047372
Labeler code
0904
Product ID
0904-7372_7a9902d5-629e-4ed5-8747-715b3a582556
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MYCOPHENOLIC ACID
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA208315
Marketing category
ANDA
Marketing start
2025-04-15
Substance
MYCOPHENOLATE SODIUM
Active strength
360 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
MYCOPHENOLIC ACID
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MYCOPHENOLATE SODIUM360 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWX877SQI1G
Rxcui485023

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
0904-7372-04MYCOPHENOLIC ACID30 in 1 CARTONTABLET, DELAYED RELEASE302
0904-7372-04MYCOPHENOLIC ACID1 in 1 BLISTER PACKTABLET, DELAYED RELEASE12
0904-7372-61MYCOPHENOLIC ACID100 in 1 CARTONTABLET, DELAYED RELEASE1002
0904-7372-61MYCOPHENOLIC ACID1 in 1 BLISTER PACKTABLET, DELAYED RELEASE12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7372-61EA - Each0904-73726f347e25-862e-4fe6-890e-ad09ff570ee412025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7372MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]1Current NDC, 4 package rows20250418_6b170816-6e5c-400c-b97b-82bbbb7d4925.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485023mycophenolic acid 360 MG Delayed Release Oral TabletPSN6b170816-6e5c-400c-b97b-82bbbb7d49252
485023mycophenolic acid 360 MG Delayed Release Oral TabletSCD6b170816-6e5c-400c-b97b-82bbbb7d49252
485023mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral TabletSY6b170816-6e5c-400c-b97b-82bbbb7d49252

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7372-040090473720430 BLISTER PACK in 1 CARTON (0904-7372-04) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK30 blister pack2025-04-15NoNoCurrent
0904-7372-6100904737261100 BLISTER PACK in 1 CARTON (0904-7372-61) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK100 blister pack2025-04-15NoNoCurrent