Mycophenolic Acid

Product NDC
72819-156
11-digit product format
728190156
Labeler code
72819
Product ID
72819-156_471a0acf-310d-7b67-e063-6294a90adb0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mycophenilic acid
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Archis Pharma LLC
Application
ANDA091248
Marketing category
ANDA
Marketing start
2022-02-21
Substance
MYCOPHENOLIC ACID
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
MYCOPHENOLIC ACID360 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHU9DX48N0T
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
72819-156-08Mycophenolic Acid120 in 1 BOTTLETABLET, DELAYED RELEASE1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72819-156-08EA - Each72819-156929e1c42-d3d6-4797-8d38-401c3ef1388f12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72819-156MYCOPHENOLIC ACID (MYCOPHENILIC ACID) TABLET, DELAYED RELEASE [ARCHIS PHARMA LLC]2Current NDC, Legacy NDC, 1 package rows20230922_30cb1078-929b-4c0f-be1d-49ef352dfab9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485020mycophenolic acid 180 MG Delayed Release Oral TabletPSN30cb1078-929b-4c0f-be1d-49ef352dfab93
485023mycophenolic acid 360 MG Delayed Release Oral TabletPSN30cb1078-929b-4c0f-be1d-49ef352dfab93
485020mycophenolic acid 180 MG Delayed Release Oral TabletSCD30cb1078-929b-4c0f-be1d-49ef352dfab93
485023mycophenolic acid 360 MG Delayed Release Oral TabletSCD30cb1078-929b-4c0f-be1d-49ef352dfab93
485020mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral TabletSY30cb1078-929b-4c0f-be1d-49ef352dfab93
485023mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral TabletSY30cb1078-929b-4c0f-be1d-49ef352dfab93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72819-156-0872819015608120 TABLET, DELAYED RELEASE in 1 BOTTLE (72819-156-08) 2022-02-210000-00-00NoNoCurrent