FDA.reportPublic FDA data

MYCOPHENOLATE MOFETIL

Product NDC
72888-192
11-digit product format
728880192
Labeler code
72888
Product ID
72888-192_f2ff4283-6a46-451e-9a9e-e7090ecf2b3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MYCOPHENOLATE MOFETIL
Dosage form
CAPSULE
Route
ORAL
Labeler
Advagen Pharma Limited
Application
ANDA210181
Marketing category
ANDA
Marketing start
2023-08-01
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, 200060

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
72888-192-01MYCOPHENOLATE MOFETIL100 in 1 BOTTLECAPSULE1006
72888-192-05MYCOPHENOLATE MOFETIL500 in 1 BOTTLECAPSULE5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-192-01EA - Each72888-1929c33900a-602a-4dde-a28c-51965404425b12023-10-16
72888-192-05EA - Each72888-192ab00b7cb-5d7f-4990-84c4-aebb2b8f100912023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-192MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ADVAGEN PHARMA LIMITED]5Current NDC, 2 package rows20240515_a15c26d8-5a27-48ba-a669-8546803d901f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199058mycophenolate mofetil 250 MG Oral CapsulePSNa15c26d8-5a27-48ba-a669-8546803d901f6
200060mycophenolate mofetil 500 MG Oral TabletPSNa15c26d8-5a27-48ba-a669-8546803d901f6
199058mycophenolate mofetil 250 MG Oral CapsuleSCDa15c26d8-5a27-48ba-a669-8546803d901f6
200060mycophenolate mofetil 500 MG Oral TabletSCDa15c26d8-5a27-48ba-a669-8546803d901f6
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
72888-192-0172888019201100 CAPSULE in 1 BOTTLE (72888-192-01) 100 capsule2023-08-01NoNoCurrent
72888-192-0572888019205500 CAPSULE in 1 BOTTLE (72888-192-05) 500 capsule2023-08-01NoNoCurrent