Mycophenolate mofetil

Product NDC
68071-3767
11-digit product format
680713767
Labeler code
68071
Product ID
68071-3767_2b9b049f-8ec4-0535-e063-6394a90afc7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolate mofetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
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
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/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
68071-3767-6Mycophenolate mofetil60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3767MYCOPHENOLATE MOFETIL TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20250115_2b9ae8ff-f2bc-ccef-e063-6294a90a76da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200060mycophenolate mofetil 500 MG Oral TabletPSN2b9ae8ff-f2bc-ccef-e063-6294a90a76da1
200060mycophenolate mofetil 500 MG Oral TabletSCD2b9ae8ff-f2bc-ccef-e063-6294a90a76da1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3767-66807137670660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68071-3767-6) 2025-01-13NoNoCurrent