FDA.reportPublic FDA data

Mycophenolate mofetil

Product NDC
82804-033
11-digit product format
828040033
Labeler code
82804
Product ID
82804-033_ce06afcb-4e6c-4b78-8bad-9909c8fffa52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolate mofetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090456
Marketing category
ANDA
Marketing start
2022-10-15
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
82804-033-30Mycophenolate mofetil30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
82804-033-60Mycophenolate mofetil60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
82804-033-90Mycophenolate mofetil90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-033-30EA - Each82804-0338a007ff9-c8e3-49dc-9d6a-0be80949048f12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-033MYCOPHENOLATE MOFETIL TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 3 package rows20231027_ce06afcb-4e6c-4b78-8bad-9909c8fffa52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200060mycophenolate mofetil 500 MG Oral TabletPSNce06afcb-4e6c-4b78-8bad-9909c8fffa521
200060mycophenolate mofetil 500 MG Oral TabletSCDce06afcb-4e6c-4b78-8bad-9909c8fffa521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-033-308280400333030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-033-30) 2023-10-25NoNoCurrent
82804-033-608280400336060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-033-60) 2023-10-25NoNoCurrent
82804-033-908280400339090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-033-90) 2023-10-25NoNoCurrent