FDA.reportPublic FDA data

mycophenolic acid

Product NDC
24979-161
11-digit product format
249790161
Labeler code
24979
Product ID
24979-161_1dc7a361-08d4-47f5-a74c-6ad4bb35a976
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mycophenolic acid
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA214289
Marketing category
ANDA
Marketing start
2021-11-08
Marketing end
2026-09-30
Substance
MYCOPHENOLATE SODIUM
Active strength
360 mg/1
Pharmacologic classes
Antimetabolite Immunosuppressant [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
mycophenolic acid

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MYCOPHENOLATE SODIUM360 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWX877SQI1G
Rxcui485020, 485023

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
24979-161-44mycophenolic acid120 in 1 BOTTLETABLET, DELAYED RELEASE1205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24979-161-44EA - Each24979-161e0e09d7d-cf21-4e7f-abac-b67dd7c94a8d12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24979-161MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [TWI PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20241009_f7c05bf9-816f-41e6-999d-bb3c7abd2627.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485020mycophenolic acid 180 MG Delayed Release Oral TabletPSNbc38bc5e-7f0a-4419-81ec-04726ce4742112
485023mycophenolic acid 360 MG Delayed Release Oral TabletPSNbc38bc5e-7f0a-4419-81ec-04726ce4742112
485020mycophenolic acid 180 MG Delayed Release Oral TabletSCDbc38bc5e-7f0a-4419-81ec-04726ce4742112
485023mycophenolic acid 360 MG Delayed Release Oral TabletSCDbc38bc5e-7f0a-4419-81ec-04726ce4742112
485020mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral TabletSYbc38bc5e-7f0a-4419-81ec-04726ce4742112
485023mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral TabletSYbc38bc5e-7f0a-4419-81ec-04726ce4742112
485020mycophenolic acid 180 MG Delayed Release Oral TabletPSNf7c05bf9-816f-41e6-999d-bb3c7abd26275
485023mycophenolic acid 360 MG Delayed Release Oral TabletPSNf7c05bf9-816f-41e6-999d-bb3c7abd26275
485020mycophenolic acid 180 MG Delayed Release Oral TabletSCDf7c05bf9-816f-41e6-999d-bb3c7abd26275
485023mycophenolic acid 360 MG Delayed Release Oral TabletSCDf7c05bf9-816f-41e6-999d-bb3c7abd26275
485020mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral TabletSYf7c05bf9-816f-41e6-999d-bb3c7abd26275
485023mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral TabletSYf7c05bf9-816f-41e6-999d-bb3c7abd26275

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24979-161-4424979016144120 TABLET, DELAYED RELEASE in 1 BOTTLE (24979-161-44) 2021-11-082026-09-30NoNoCurrent