Mycophenolate Mofetil

Product NDC
65050-2073
11-digit product format
650502073
Labeler code
65050
Product ID
65050-2073_42d339f9-3fb1-6882-e063-6294a90a3012
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolate Mofetil
Dosage form
CAPSULE
Route
ORAL
Labeler
Wuxi Fortune Pharmaceutical Co.,Ltd.
Application
ANDA214079
Marketing category
ANDA
Marketing start
2025-11-10
Substance
MYCOPHENOLATE MOFETIL
Active strength
250 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
Mycophenolate Mofetil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MYCOPHENOLATE MOFETIL250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9242ECW6R0
Rxcui199058

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
65050-2073-0Mycophenolate Mofetil100 in 1 BOTTLE, PLASTICCAPSULE1002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199058mycophenolate mofetil 250 MG Oral CapsulePSNca633c6a-1e58-4faa-8e5d-71f89cefaa012
199058mycophenolate mofetil 250 MG Oral CapsuleSCDca633c6a-1e58-4faa-8e5d-71f89cefaa012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65050-2073-065050207300100 CAPSULE in 1 BOTTLE, PLASTIC (65050-2073-0) 100 capsule2025-11-10NoNoCurrent