FDA.reportPublic FDA data

mycophenolate mofetil

Product NDC
83270-000
11-digit product format
832700000
Labeler code
83270
Product ID
83270-000_42ed2be4-bc3d-281a-e063-6394a90aeb7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mycophenolate mofetil
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
ONESOURCE SPECIALTY PHARMA LIMITED
Application
ANDA216390
Marketing category
ANDA
Marketing start
2023-04-30
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
267b34ba-ace4-4048-9f21-d3c7ac983fc3Product name920210224
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83270-000-04mycophenolate mofetil4 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,47
83270-000-04mycophenolate mofetil20 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,207

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83270-000MYCOPHENOLATE MOFETIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ONESOURCE SPECIALTY PHARMA LIMITED]6Current NDC, 2 package rows20250523_461a252f-ff81-4e08-b256-a497b14835fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311881mycophenolate mofetil 500 MG InjectionPSN461a252f-ff81-4e08-b256-a497b14835fa7
311881mycophenolate mofetil 500 MG InjectionSCD461a252f-ff81-4e08-b256-a497b14835fa7
311881mycophenolate mofetil (as mycophenolate mofetil hydrochloride) 500 MG InjectionSY461a252f-ff81-4e08-b256-a497b14835fa7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83270-000-04832700000044 VIAL in 1 CARTON (83270-000-04) / 20 mL in 1 VIAL4 vial2023-04-30NoNoHistorical