Mycophenolate mofetil

Product NDC
0904-7078
11-digit product format
009047078
Labeler code
0904
Product ID
0904-7078_a4969278-2c6f-4b4f-afc3-0741d9f24436
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolate mofetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA090456
Marketing category
ANDA
Marketing start
2010-11-06
Substance
MYCOPHENOLATE MOFETIL
Active strength
500 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
Mycophenolate mofetil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MYCOPHENOLATE MOFETIL500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9242ECW6R0
Rxcui200060

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
0904-7078-61Mycophenolate mofetil1 in 1 BLISTER PACKTABLET, FILM COATED16
0904-7078-61Mycophenolate mofetil100 in 1 CARTONTABLET, FILM COATED1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7078-61EA - Each0904-70786775fbf5-3ae5-499f-b6b8-89a4ba04d51612021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7078MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MAJOR PHARMACEUTICALS]3Current NDC, Legacy NDC, 2 package rows20241018_d176199c-dc3f-48c8-b7d2-c5d0a6a242fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200060mycophenolate mofetil 500 MG Oral TabletPSNd176199c-dc3f-48c8-b7d2-c5d0a6a242fe6
200060mycophenolate mofetil 500 MG Oral TabletSCDd176199c-dc3f-48c8-b7d2-c5d0a6a242fe6
200060mycophenolate mofetil 500 MG Oral TabletPSNf2eafcbb-77ab-461e-aa09-9cc4123eb3bd4
200060mycophenolate mofetil 500 MG Oral TabletSCDf2eafcbb-77ab-461e-aa09-9cc4123eb3bd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7078-6100904707861100 BLISTER PACK in 1 CARTON (0904-7078-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2010-11-060000-00-00NoNoCurrent