MYCOPHENOLIC ACID

Product NDC
50090-6492
11-digit product format
500906492
Labeler code
50090
Product ID
50090-6492_8f6a9480-989d-4f54-a0f9-344d4fca1b8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MYCOPHENOLIC ACID
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208315
Marketing category
ANDA
Marketing start
2021-09-24
Substance
MYCOPHENOLATE SODIUM
Active strength
360 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
MYCOPHENOLIC ACID
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MYCOPHENOLATE SODIUM360 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWX877SQI1G
Rxcui485023

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
50090-6492-0MYCOPHENOLIC ACID180 in 1 BOTTLETABLET, DELAYED RELEASE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6492-0EA - Each50090-64928d047663-38c8-4792-87fd-1c93ce9fda9412023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6492MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20230525_8b73dc87-c611-4bcb-8852-532eb388cb2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485023mycophenolic acid 360 MG Delayed Release Oral TabletPSN8b73dc87-c611-4bcb-8852-532eb388cb2e1
485023mycophenolic acid 360 MG Delayed Release Oral TabletSCD8b73dc87-c611-4bcb-8852-532eb388cb2e1
485023mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral TabletSY8b73dc87-c611-4bcb-8852-532eb388cb2e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6492-050090649200180 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-6492-0) 2023-05-22NoNoCurrent