MYCOPHENOLATE MOFETIL

Product NDC
23155-848
11-digit product format
231550848
Labeler code
23155
Product ID
23155-848_b5316b1d-ed7b-426d-9b86-dd17018c97a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MYCOPHENOLATE MOFETIL
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA212634
Marketing category
ANDA
Marketing start
2023-09-05
Marketing end
2028-02-29
Substance
MYCOPHENOLATE MOFETIL
Active strength
200 mg/mL
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-848-51MYCOPHENOLATE MOFETIL225 mL in 1 BOTTLE, PLASTICPOWDER, FOR SUSPENSION2252
23155-848-51MYCOPHENOLATE MOFETIL1 in 1 CARTONPOWDER, FOR SUSPENSION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-848-51ML - Milliliter23155-8487791524e-062b-4a43-8a27-37ff4b0aafbc12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-848MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]1Current NDC, 2 package rows20230905_df3ba2e9-00bb-40af-8658-2c5fd2e398ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311880mycophenolate mofetil 200 MG in 1 mL Oral SuspensionPSNdf3ba2e9-00bb-40af-8658-2c5fd2e398ef2
311880mycophenolate mofetil 200 MG/ML Oral SuspensionSCDdf3ba2e9-00bb-40af-8658-2c5fd2e398ef2
311880mycophenolate mofetil 200 MG per 1 ML Oral SuspensionSYdf3ba2e9-00bb-40af-8658-2c5fd2e398ef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
23155-848-51231550848511 BOTTLE, PLASTIC in 1 CARTON (23155-848-51) / 225 mL in 1 BOTTLE, PLASTIC2023-09-052028-02-29NoNoHistorical