FDA.reportPublic FDA data

Mycophenolate Mofetil

Product NDC
60219-1595
11-digit product format
602191595
Labeler code
60219
Product ID
60219-1595_545a5c62-f746-4667-91ec-68673bfa787f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolate Mofetil
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA214871
Marketing category
ANDA
Marketing start
2024-03-21
Substance
MYCOPHENOLATE MOFETIL
Active strength
200 mg/mL
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 MOFETIL200 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9242ECW6R0
Rxcui311880

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60219-1595-2Mycophenolate Mofetil1 in 1 CARTONPOWDER, FOR SUSPENSION12
60219-1595-2Mycophenolate Mofetil225 mL in 1 BOTTLE, PLASTICPOWDER, FOR SUSPENSION2252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-1595-2ML - Milliliter60219-15952eebb143-b03d-44d9-a65c-d0e9272db36c12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-1595MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [AMNEAL PHARMACEUTICALS NY LLC]1Current NDC, 2 package rows20240322_5d7f7b88-79e3-4a56-a9f3-796c28049a60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311880mycophenolate mofetil 200 MG in 1 mL Oral SuspensionPSN5d7f7b88-79e3-4a56-a9f3-796c28049a602
311880mycophenolate mofetil 200 MG/ML Oral SuspensionSCD5d7f7b88-79e3-4a56-a9f3-796c28049a602
311880mycophenolate mofetil 200 MG per 1 ML Oral SuspensionSY5d7f7b88-79e3-4a56-a9f3-796c28049a602

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60219-1595-2602191595021 BOTTLE, PLASTIC in 1 CARTON (60219-1595-2) / 225 mL in 1 BOTTLE, PLASTIC2024-03-21NoNoCurrent