FDA.reportPublic FDA data

Mycophenolate mofetil

Product NDC
59651-624
11-digit product format
596510624
Labeler code
59651
Product ID
59651-624_19947991-db65-4143-a57c-dc180d695426
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolate mofetil
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA217828
Marketing category
ANDA
Marketing start
2024-01-05
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
59651-624-01Mycophenolate mofetil100 in 1 BOTTLECAPSULE1002
59651-624-05Mycophenolate mofetil500 in 1 BOTTLECAPSULE5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-624-01EA - Each59651-624f653b3b3-be44-44c4-a159-a7176faf2b7312024-04-05
59651-624-05EA - Each59651-624e5018ef3-2412-4583-b6ac-a82c882e82a712024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-624MYCOPHENOLATE MOFETIL CAPSULE [AUROBINDO PHARMA LIMITED]1Current NDC, 2 package rows20240112_3eb584dc-f72d-4545-96fa-ab3d47be41ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199058mycophenolate mofetil 250 MG Oral CapsulePSN3eb584dc-f72d-4545-96fa-ab3d47be41ce2
199058mycophenolate mofetil 250 MG Oral CapsuleSCD3eb584dc-f72d-4545-96fa-ab3d47be41ce2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-624-0159651062401100 CAPSULE in 1 BOTTLE (59651-624-01) 100 capsule2024-01-05NoNoHistorical
59651-624-0559651062405500 CAPSULE in 1 BOTTLE (59651-624-05) 500 capsule2024-01-05NoNoHistorical