FDA.reportPublic FDA data

Mycophenolate Mofetil

Product NDC
54288-141
11-digit product format
542880141
Labeler code
54288
Product ID
54288-141_1a8abd3a-6834-4468-a443-ca95e795b17d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolate Mofetil hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
BPI Labs LLC
Application
ANDA214283
Marketing category
ANDA
Marketing start
2023-03-08
Substance
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Active strength
500 mg/20mL
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
Mycophenolate Mofetil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MYCOPHENOLATE MOFETIL HYDROCHLORIDE500 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUXH81S8ZVB
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54288-141-042025-02-14C16284748780-12cef2736-a333-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL FOR INJECTION safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL FOR INJECTION. MYCOPHENOLATE MOFETIL for injection, for intravenous use Initial U.S. Approval: 1995
54288-141-042025-01-30C16284748780-12cef2736-a333-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL FOR INJECTION safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL FOR INJECTION. MYCOPHENOLATE MOFETIL for injection, for intravenous use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54288-141-04Mycophenolate Mofetil20 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,205
54288-141-04Mycophenolate Mofetil4 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,45

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54288-141-04EA - Each54288-14118f29f2f-ce26-437b-a99d-e588019942e312023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54288-141MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BPI LABS LLC]4Current NDC, 2 package rows20250216_32001417-130d-4c08-8e63-94ba3627ce5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311881mycophenolate mofetil 500 MG InjectionPSN32001417-130d-4c08-8e63-94ba3627ce5f5
311881mycophenolate mofetil 500 MG InjectionSCD32001417-130d-4c08-8e63-94ba3627ce5f5
311881mycophenolate mofetil (as mycophenolate mofetil hydrochloride) 500 MG InjectionSY32001417-130d-4c08-8e63-94ba3627ce5f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54288-141-04542880141044 VIAL in 1 CARTON (54288-141-04) / 20 mL in 1 VIAL4 vial2023-03-08NoNoCurrent