FDA.reportPublic FDA data

mycophenolate mofetil

Product NDC
60687-885
11-digit product format
606870885
Labeler code
60687
Product ID
60687-885_2f8663a1-6d47-1d0e-e063-6394a90ac57f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mycophenolate mofetil
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA200197
Marketing category
ANDA
Marketing start
2025-03-02
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
60687-885-01mycophenolate mofetil100 in 1 CARTONCAPSULE1002
60687-885-11mycophenolate mofetil1 in 1 BLISTER PACKCAPSULE12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-885-01EA - Each60687-8853cc1feb5-3ea6-4275-a13b-dca440dbcf7712025-03-04
60687-885-11EA - Each60687-8859d320b67-8b4d-40fb-b7ec-abc23ebde8bc12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-885MYCOPHENOLATE MOFETIL CAPSULE [AMERICAN HEALTH PACKAGING]2Current NDC, 2 package rows20250312_75a76397-bb62-4014-8488-949a711b25f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199058mycophenolate mofetil 250 MG Oral CapsulePSN75a76397-bb62-4014-8488-949a711b25f02
199058mycophenolate mofetil 250 MG Oral CapsuleSCD75a76397-bb62-4014-8488-949a711b25f02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-885-0160687088501100 BLISTER PACK in 1 CARTON (60687-885-01) / 1 CAPSULE in 1 BLISTER PACK (60687-885-11) 100 blister pack2025-03-02NoNoCurrent
60687-885-11606870885111 in 1 BLISTER PACKHistorical