Mycophenolic Acid

Product NDC
70377-040
11-digit product format
703770040
Labeler code
70377
Product ID
70377-040_c88acb03-1331-2837-85be-e4de5c5ad539
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolic Acid
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Biocon Pharma Inc.
Application
ANDA214630
Marketing category
ANDA
Marketing start
2022-05-30
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
70377-040-11Mycophenolic Acid120 in 1 BOTTLETABLET, DELAYED RELEASE1209

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70377-040MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [BIOCON PHARMA INC.]8Current NDC, Legacy NDC, 1 package rows20220619_8516e135-5cc0-ef2d-6dad-0f9f841bb27b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485020mycophenolic acid 180 MG Delayed Release Oral TabletPSN8516e135-5cc0-ef2d-6dad-0f9f841bb27b9
485023mycophenolic acid 360 MG Delayed Release Oral TabletPSN8516e135-5cc0-ef2d-6dad-0f9f841bb27b9
485020mycophenolic acid 180 MG Delayed Release Oral TabletSCD8516e135-5cc0-ef2d-6dad-0f9f841bb27b9
485023mycophenolic acid 360 MG Delayed Release Oral TabletSCD8516e135-5cc0-ef2d-6dad-0f9f841bb27b9
485020mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral TabletSY8516e135-5cc0-ef2d-6dad-0f9f841bb27b9
485023mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral TabletSY8516e135-5cc0-ef2d-6dad-0f9f841bb27b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70377-040-1170377004011120 TABLET, DELAYED RELEASE in 1 BOTTLE (70377-040-11) 2022-05-300000-00-00NoNoCurrent