FDA.reportPublic FDA data

Mycophenolate Mofetil

Product NDC
60687-494
11-digit product format
606870494
Labeler code
60687
Product ID
60687-494_2b22a637-a862-0038-e063-6294a90a2296
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolate Mofetil
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA065410
Marketing category
ANDA
Marketing start
2020-02-21
Marketing end
2026-06-30
Substance
MYCOPHENOLATE MOFETIL
Active strength
250 mg/1
Pharmacologic classes
Antimetabolite Immunosuppressant [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mycophenolate Mofetil

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
60687-494-01Mycophenolate Mofetil100 in 1 BOX, UNIT-DOSECAPSULE1006
60687-494-11Mycophenolate Mofetil1 in 1 BLISTER PACKCAPSULE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-494-01EA - Each60687-494a94e449c-9853-4cd8-9986-b8d99587c68b12020-03-10
60687-494-11EA - Each60687-49412be9f66-e260-44b1-a19d-f2d2ce412f6d12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-494MYCOPHENOLATE MOFETIL CAPSULE [AMERICAN HEALTH PACKAGING]6Current NDC, Legacy NDC, 2 package rows20250109_54e8bbc4-1f6b-4a15-8142-a8bac5ba8d49.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199058mycophenolate mofetil 250 MG Oral CapsulePSN54e8bbc4-1f6b-4a15-8142-a8bac5ba8d496
199058mycophenolate mofetil 250 MG Oral CapsuleSCD54e8bbc4-1f6b-4a15-8142-a8bac5ba8d496

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-494-0160687049401100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-494-01) / 1 CAPSULE in 1 BLISTER PACK (60687-494-11) 100 blister pack2020-02-212026-06-30NoNoCurrent
60687-494-11606870494111 in 1 BLISTER PACKHistorical