FDA.reportPublic FDA data

Mycophenolic Acid

Product NDC
16729-189
11-digit product format
167290189
Labeler code
16729
Product ID
16729-189_0f1eadde-f71c-76cb-e063-6294a90af04c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolic Acid
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA202555
Marketing category
ANDA
Marketing start
2017-09-11
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
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
16729-189-16Mycophenolic Acid500 in 1 BOTTLETABLET, DELAYED RELEASE5007
16729-189-29Mycophenolic Acid120 in 1 BOTTLETABLET, DELAYED RELEASE1207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-189-29EA - Each16729-1891175ac00-1bc4-49a1-8c83-fab3ed5d78c812017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-189MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [ACCORD HEALTHCARE INC.]7Current NDC, Legacy NDC, 2 package rows20240118_dc24aa15-330c-4698-872f-159d7e582b4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485020mycophenolic acid 180 MG Delayed Release Oral TabletPSNdc24aa15-330c-4698-872f-159d7e582b4b7
485023mycophenolic acid 360 MG Delayed Release Oral TabletPSNdc24aa15-330c-4698-872f-159d7e582b4b7
485020mycophenolic acid 180 MG Delayed Release Oral TabletSCDdc24aa15-330c-4698-872f-159d7e582b4b7
485023mycophenolic acid 360 MG Delayed Release Oral TabletSCDdc24aa15-330c-4698-872f-159d7e582b4b7
485020mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral TabletSYdc24aa15-330c-4698-872f-159d7e582b4b7
485023mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral TabletSYdc24aa15-330c-4698-872f-159d7e582b4b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-189-1616729018916500 TABLET, DELAYED RELEASE in 1 BOTTLE (16729-189-16) 2026-01-01NoNoHistorical
16729-189-2916729018929120 TABLET, DELAYED RELEASE in 1 BOTTLE (16729-189-29) 2017-09-110000-00-00NoNoCurrent