mycophenolate mofetil

Product NDC
63629-9582
11-digit product format
636299582
Labeler code
63629
Product ID
63629-9582_06449b80-39e1-4ffa-8970-3263c823c008
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mycophenolate mofetil
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA065416
Marketing category
ANDA
Marketing start
2009-05-04
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
267b34ba-ace4-4048-9f21-d3c7ac983fc3Product name920210224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-9582-1mycophenolate mofetil120 in 1 BOTTLETABLET120103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9582MYCOPHENOLATE MOFETIL TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240511_0f1704e2-a66a-4be5-8127-ebb5947c7b64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200060mycophenolate mofetil 500 MG Oral TabletPSN0f1704e2-a66a-4be5-8127-ebb5947c7b64103
200060mycophenolate mofetil 500 MG Oral TabletSCD0f1704e2-a66a-4be5-8127-ebb5947c7b64103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9582-163629958201120 TABLET in 1 BOTTLE (63629-9582-1) 120 tablet2022-11-150000-00-00NoNoCurrent