FDA.reportPublic FDA data

Mycophenolic Acid

Product NDC
0904-6786
11-digit product format
009046786
Labeler code
0904
Product ID
0904-6786_2f8a7866-b1bb-4a5a-81b6-ca27f6543eb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolic Acid
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA091558
Marketing category
ANDA
Marketing start
2014-08-19
Substance
MYCOPHENOLATE SODIUM
Active strength
360 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 SODIUM360 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
0904-6786-04Mycophenolic Acid30 in 1 CARTONTABLET, DELAYED RELEASE305
0904-6786-04Mycophenolic Acid1 in 1 BLISTER PACKTABLET, DELAYED RELEASE15
0904-6786-61Mycophenolic Acid100 in 1 CARTONTABLET, DELAYED RELEASE1005
0904-6786-61Mycophenolic Acid1 in 1 BLISTER PACKTABLET, DELAYED RELEASE15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6786-04EA - Each0904-678668ba42c1-3f2d-46a9-a0cd-c599ec77a4fa12019-05-02
0904-6786-61EA - Each0904-678612a9186d-0ab3-4410-9a5f-b1d75234f71d12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6786MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]4Current NDC, Legacy NDC, 4 package rows20240815_93763b39-ba21-449b-bdc5-254ba57154e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485020mycophenolic acid 180 MG Delayed Release Oral TabletPSN93763b39-ba21-449b-bdc5-254ba57154e45
485023mycophenolic acid 360 MG Delayed Release Oral TabletPSN93763b39-ba21-449b-bdc5-254ba57154e45
485020mycophenolic acid 180 MG Delayed Release Oral TabletSCD93763b39-ba21-449b-bdc5-254ba57154e45
485023mycophenolic acid 360 MG Delayed Release Oral TabletSCD93763b39-ba21-449b-bdc5-254ba57154e45
485020mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral TabletSY93763b39-ba21-449b-bdc5-254ba57154e45
485023mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral TabletSY93763b39-ba21-449b-bdc5-254ba57154e45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6786-040090467860430 BLISTER PACK in 1 CARTON (0904-6786-04) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK30 blister pack2014-08-190000-00-00NoNoCurrent
0904-6786-6100904678661100 BLISTER PACK in 1 CARTON (0904-6786-61) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK100 blister pack2014-08-190000-00-00NoNoCurrent