FDA.reportPublic FDA data

mycophenolate mofetil

Product NDC
72485-415
11-digit product format
724850415
Labeler code
72485
Product ID
72485-415_42edff88-f01d-0908-e063-6294a90a3b0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mycophenolate mofetil
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
ARMAS PHARMACEUTICALS INC
Application
ANDA216390
Marketing category
ANDA
Marketing start
2023-07-06
Substance
MYCOPHENOLATE MOFETIL
Active strength
500 mg/20mL
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
mycophenolate mofetil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MYCOPHENOLATE MOFETIL500 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9242ECW6R0
Rxcui311881

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
72485-415-04mycophenolate mofetil4 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,44
72485-415-04mycophenolate mofetil20 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-415-04EA - Each72485-4158f2bdb0e-0b92-44b5-a488-29bc0cf1cfc312023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-415MYCOPHENOLATE MOFETIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ARMAS PHARMACEUTICALS INC]3Current NDC, 2 package rows20250523_ffcc237c-f31b-77b8-e053-6294a90a603e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311881mycophenolate mofetil 500 MG InjectionPSNffcc237c-f31b-77b8-e053-6294a90a603e4
311881mycophenolate mofetil 500 MG InjectionSCDffcc237c-f31b-77b8-e053-6294a90a603e4
311881mycophenolate mofetil (as mycophenolate mofetil hydrochloride) 500 MG InjectionSYffcc237c-f31b-77b8-e053-6294a90a603e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72485-415-04724850415044 VIAL in 1 CARTON (72485-415-04) / 20 mL in 1 VIAL4 vial2023-07-06NoNoHistorical