Mycophenolic Acid

Product NDC
70436-173
11-digit product format
704360173
Labeler code
70436
Product ID
70436-173_51c21a8c-f6ac-8005-e063-6294a90a8028
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolic Acid
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA214376
Marketing category
ANDA
Marketing start
2021-05-19
Substance
MYCOPHENOLATE SODIUM
Active strength
360 mg/1
Pharmacologic classes
Antimetabolite Immunosuppressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mycophenolic Acid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MYCOPHENOLATE SODIUM360 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWX877SQI1G

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
70436-173-23Mycophenolic Acid120 in 1 BOTTLETABLET, DELAYED RELEASE12012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-173MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [SLATE RUN PHARMACEUTICALS, LLC]11Current NDC, Legacy NDC, 1 package rows20240620_c1ce92ef-4102-1487-e053-2995a90ac521.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485020mycophenolic acid 180 MG Delayed Release Oral TabletPSNc1ce92ef-4102-1487-e053-2995a90ac52113
485023mycophenolic acid 360 MG Delayed Release Oral TabletPSNc1ce92ef-4102-1487-e053-2995a90ac52113
485020mycophenolic acid 180 MG Delayed Release Oral TabletSCDc1ce92ef-4102-1487-e053-2995a90ac52113
485023mycophenolic acid 360 MG Delayed Release Oral TabletSCDc1ce92ef-4102-1487-e053-2995a90ac52113
485020mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral TabletSYc1ce92ef-4102-1487-e053-2995a90ac52113
485023mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral TabletSYc1ce92ef-4102-1487-e053-2995a90ac52113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70436-173-2370436017323120 TABLET, DELAYED RELEASE in 1 BOTTLE (70436-173-23) 2021-05-190000-00-00NoNoCurrent