MYCOPHENOLATE MOFETIL

Product NDC
70518-4036
11-digit product format
705184036
Labeler code
70518
Product ID
70518-4036_3f9fc1fe-87b8-a8cf-e063-6394a90a2c38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MYCOPHENOLATE MOFETIL
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210181
Marketing category
ANDA
Marketing start
2024-03-11
Substance
MYCOPHENOLATE MOFETIL
Active strength
250 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 MOFETIL250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9242ECW6R0
Rxcui199058

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
70518-4036-0MYCOPHENOLATE MOFETIL100 in 1 BOXCAPSULE1004
70518-4036-1MYCOPHENOLATE MOFETIL1 in 1 POUCHCAPSULE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4036MYCOPHENOLATE MOFETIL CAPSULE [REMEDYREPACK INC.]3Current NDC, 2 package rows20240725_d203775c-bf36-460c-bacf-3ab2348a514f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199058mycophenolate mofetil 250 MG Oral CapsulePSNd203775c-bf36-460c-bacf-3ab2348a514f4
199058mycophenolate mofetil 250 MG Oral CapsuleSCDd203775c-bf36-460c-bacf-3ab2348a514f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4036-070518403600100 POUCH in 1 BOX (70518-4036-0) / 1 CAPSULE in 1 POUCH (70518-4036-1) 100 pouch2024-03-11NoNoCurrent
70518-4036-1705184036011 in 1 POUCHHistorical