FDA.reportPublic FDA data

MYCOPHENOLATE MOFETIL

Product NDC
68254-5003
11-digit product format
682545003
Labeler code
68254
Product ID
68254-5003_6eb2ddd0-ab23-44ae-a1ce-acc44e4f7e29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MYCOPHENOLATE MOFETIL
Dosage form
TABLET
Route
ORAL
Labeler
CONCORD BIOTECH LIMITED
Application
ANDA212087
Marketing category
ANDA
Marketing start
2020-12-21
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
Rxcui199058, 200060

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
68254-5003-1MYCOPHENOLATE MOFETIL30 in 1 BOTTLETABLET3018
68254-5003-2MYCOPHENOLATE MOFETIL100 in 1 BOTTLETABLET10018
68254-5003-3MYCOPHENOLATE MOFETIL500 in 1 BOTTLETABLET50018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68254-5003MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [CONCORD BIOTECH LIMITED]17Current NDC, Legacy NDC, 3 package rows20240514_64ac00ee-298c-49cf-a91c-78019a0d014d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199058mycophenolate mofetil 250 MG Oral CapsulePSN64ac00ee-298c-49cf-a91c-78019a0d014d18
200060mycophenolate mofetil 500 MG Oral TabletPSN64ac00ee-298c-49cf-a91c-78019a0d014d18
199058mycophenolate mofetil 250 MG Oral CapsuleSCD64ac00ee-298c-49cf-a91c-78019a0d014d18
200060mycophenolate mofetil 500 MG Oral TabletSCD64ac00ee-298c-49cf-a91c-78019a0d014d18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68254-5003-16825450030130 TABLET in 1 BOTTLE (68254-5003-1) 30 tablet2020-12-210000-00-00NoNoCurrent
68254-5003-268254500302100 TABLET in 1 BOTTLE (68254-5003-2) 100 tablet2020-12-210000-00-00NoNoCurrent
68254-5003-368254500303500 TABLET in 1 BOTTLE (68254-5003-3) 500 tablet2020-12-210000-00-00NoNoCurrent