FDA.reportPublic FDA data

Mycophenolate Mofetil

Product NDC
42023-172
11-digit product format
420230172
Labeler code
42023
Product ID
42023-172_1df5a45a-835a-454f-b9b1-5265b801cdca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mycophenolate mofetil
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Par Health USA, LLC
Application
ANDA203575
Marketing category
ANDA
Marketing start
2016-10-28
Substance
MYCOPHENOLATE MOFETIL
Active strength
500 mg/20mL
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
Mycophenolate Mofetil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MYCOPHENOLATE MOFETIL500 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9242ECW6R0
Rxcui311881

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04b26d3d-97dc-48db-824b-10b299945382Product name820250224
1aa45098-03f9-4bf8-b28d-2566aa0f7f4bProduct name120250218
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
267b34ba-ace4-4048-9f21-d3c7ac983fc3Product name920210224
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42023-172-04Mycophenolate Mofetil4 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,423
42023-172-04Mycophenolate Mofetil20 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,2023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-172-04EA - Each42023-172fd95b559-0df1-4b0e-8c0a-47cf1ba9547c12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42023-172MYCOPHENOLATE MOFETIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.]12Current NDC, Legacy NDC, 2 package rows20240913_35ba0428-e267-49a5-99a9-c58853f7989d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311881mycophenolate mofetil 500 MG InjectionPSN35ba0428-e267-49a5-99a9-c58853f7989d23
311881mycophenolate mofetil 500 MG InjectionSCD35ba0428-e267-49a5-99a9-c58853f7989d23
311881mycophenolate mofetil (as mycophenolate mofetil hydrochloride) 500 MG InjectionSY35ba0428-e267-49a5-99a9-c58853f7989d23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42023-172-04420230172044 VIAL in 1 CARTON (42023-172-04) / 20 mL in 1 VIAL4 vial2016-10-280000-00-00NoNoCurrent