FDA.reportPublic FDA data

Mycophenolate mofetil

Product NDC
23155-836
11-digit product format
231550836
Labeler code
23155
Product ID
23155-836_4c6ca7cd-80b3-4703-904c-6d6d78965f4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolate mofetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA090456
Marketing category
ANDA
Marketing start
2022-10-15
Marketing end
2028-05-31
Substance
MYCOPHENOLATE MOFETIL
Active strength
500 mg/1
Pharmacologic classes
Antimetabolite Immunosuppressant [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mycophenolate mofetil

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MYCOPHENOLATE MOFETIL500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9242ECW6R0
Rxcui199058, 200060

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
23155-836-01Mycophenolate mofetil100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1003
23155-836-05Mycophenolate mofetil500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-836-01EA - Each23155-8367210257b-36e0-4b67-aab1-2a40b944da7e12023-01-09
23155-836-05EA - Each23155-836960d1d0c-a3f1-4d03-b9e6-8d56c9852bae12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-836MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 2 package rows20240110_3ac54299-15cc-4c7a-8831-60c15a859b85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199058mycophenolate mofetil 250 MG Oral CapsulePSN3ac54299-15cc-4c7a-8831-60c15a859b853
200060mycophenolate mofetil 500 MG Oral TabletPSN3ac54299-15cc-4c7a-8831-60c15a859b853
199058mycophenolate mofetil 250 MG Oral CapsuleSCD3ac54299-15cc-4c7a-8831-60c15a859b853
200060mycophenolate mofetil 500 MG Oral TabletSCD3ac54299-15cc-4c7a-8831-60c15a859b853
200060mycophenolate mofetil 500 MG Oral TabletPSN84c6f6bb-8924-4da5-9629-126197195f831
200060mycophenolate mofetil 500 MG Oral TabletPSNce06afcb-4e6c-4b78-8bad-9909c8fffa521
200060mycophenolate mofetil 500 MG Oral TabletSCD84c6f6bb-8924-4da5-9629-126197195f831
200060mycophenolate mofetil 500 MG Oral TabletSCDce06afcb-4e6c-4b78-8bad-9909c8fffa521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
23155-836-0123155083601100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (23155-836-01) 2022-10-152027-12-31NoNoCurrent
23155-836-0523155083605500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (23155-836-05) 2022-10-152028-05-31NoNoCurrent