mycophenolic acid

Product NDC
72789-247
11-digit product format
727890247
Labeler code
72789
Product ID
72789-247_2d6ca67b-c928-0b22-e063-6394a90a45f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mycophenolic acid
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA214289
Marketing category
ANDA
Marketing start
2021-11-08
Substance
MYCOPHENOLATE SODIUM
Active strength
180 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 SODIUM180 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
72789-247-98mycophenolic acid120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE12012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-247-98EA - Each72789-247eb57b2df-d62d-4514-8e8e-a9bac724360d12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-247MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]12Current NDC, Legacy NDC, 1 package rows20250207_bc38bc5e-7f0a-4419-81ec-04726ce47421.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485020mycophenolic acid 180 MG Delayed Release Oral TabletPSNbc38bc5e-7f0a-4419-81ec-04726ce4742112
485023mycophenolic acid 360 MG Delayed Release Oral TabletPSNbc38bc5e-7f0a-4419-81ec-04726ce4742112
485020mycophenolic acid 180 MG Delayed Release Oral TabletSCDbc38bc5e-7f0a-4419-81ec-04726ce4742112
485023mycophenolic acid 360 MG Delayed Release Oral TabletSCDbc38bc5e-7f0a-4419-81ec-04726ce4742112
485020mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral TabletSYbc38bc5e-7f0a-4419-81ec-04726ce4742112
485023mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral TabletSYbc38bc5e-7f0a-4419-81ec-04726ce4742112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-247-9872789024798120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-247-98) 2022-04-190000-00-00NoNoCurrent