Mycophenolate mofetil

Product NDC
70518-4377
11-digit product format
705184377
Labeler code
70518
Product ID
70518-4377_38dd4fa9-8b2d-47b6-e063-6294a90a1b7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolate mofetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090456
Marketing category
ANDA
Marketing start
2025-06-30
Substance
MYCOPHENOLATE MOFETIL
Active strength
500 mg/1
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 MOFETIL500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9242ECW6R0
Rxcui200060

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
70518-4377-0Mycophenolate mofetil100 in 1 BOXTABLET, FILM COATED1001
70518-4377-1Mycophenolate mofetil1 in 1 POUCHTABLET, FILM COATED11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200060mycophenolate mofetil 500 MG Oral TabletPSN84c6f6bb-8924-4da5-9629-126197195f831
200060mycophenolate mofetil 500 MG Oral TabletSCD84c6f6bb-8924-4da5-9629-126197195f831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4377-070518437700100 POUCH in 1 BOX (70518-4377-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4377-1) 100 pouch2025-06-30NoNoHistorical
70518-4377-1705184377011 in 1 POUCHHistorical