FDA.reportPublic FDA data

Mycophenolate Mofetil

Product NDC
31722-879
11-digit product format
317220879
Labeler code
31722
Product ID
31722-879_48432e06-b34c-4277-e063-6394a90a6ba0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolate Mofetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA208119
Marketing category
ANDA
Marketing start
2024-10-22
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
267b34ba-ace4-4048-9f21-d3c7ac983fc3Product name920210224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-879-01Mycophenolate Mofetil100 in 1 BOTTLETABLET, FILM COATED1002
31722-879-05Mycophenolate Mofetil500 in 1 BOTTLETABLET, FILM COATED5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-879-01EA - Each31722-879f5f194d3-9810-4e15-b1b4-649d274f90a212025-03-04
31722-879-05EA - Each31722-87954fcf219-9783-4fde-a107-b8924989da4212025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-879MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20241109_c3ded171-89da-4644-9ee8-dbcf6258036f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200060mycophenolate mofetil 500 MG Oral TabletPSNc3ded171-89da-4644-9ee8-dbcf6258036f2
200060mycophenolate mofetil 500 MG Oral TabletSCDc3ded171-89da-4644-9ee8-dbcf6258036f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-879-0131722087901100 TABLET, FILM COATED in 1 BOTTLE (31722-879-01) 2024-10-22NoNoHistorical
31722-879-0531722087905500 TABLET, FILM COATED in 1 BOTTLE (31722-879-05) 2024-10-22NoNoHistorical