FDA.reportPublic FDA data

Myfortic

Product NDC
0078-0385
11-digit product format
000780385
Labeler code
0078
Product ID
0078-0385_c5665f04-bf64-4cc7-b98b-171a8f57155b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mycophenolic acid
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA050791
Marketing category
NDA
Marketing start
2004-02-27
Substance
MYCOPHENOLATE SODIUM
Active strength
180 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
Myfortic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MYCOPHENOLATE SODIUM180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWX877SQI1G
Rxcui485020, 485023, 616449, 616450

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
0078-0385-66Myfortic120 in 1 BOTTLETABLET, DELAYED RELEASE12035

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0385-66EA - Each0078-0385d7c0eecb-e87f-4aea-afa5-8cc0ec84534112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MYCOPHENOLATE SODIUMACTIVE INGREDIENTWX877SQI1GMYFORTIC (MYCOPHENOLIC ACID) TABLET, DELAYED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]19
MYCOPHENOLIC ACIDACTIVE MOIETYHU9DX48N0TMYFORTIC (MYCOPHENOLIC ACID) TABLET, DELAYED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]19
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMYFORTIC (MYCOPHENOLIC ACID) TABLET, DELAYED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]19
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMYFORTIC (MYCOPHENOLIC ACID) TABLET, DELAYED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]19
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMYFORTIC (MYCOPHENOLIC ACID) TABLET, DELAYED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]19
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MYFORTIC (MYCOPHENOLIC ACID) TABLET, DELAYED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]19
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMYFORTIC (MYCOPHENOLIC ACID) TABLET, DELAYED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]19
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMYFORTIC (MYCOPHENOLIC ACID) TABLET, DELAYED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]19
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MYFORTIC (MYCOPHENOLIC ACID) TABLET, DELAYED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]19
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMYFORTIC (MYCOPHENOLIC ACID) TABLET, DELAYED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]19
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MYFORTIC (MYCOPHENOLIC ACID) TABLET, DELAYED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]19
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMYFORTIC (MYCOPHENOLIC ACID) TABLET, DELAYED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]19
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMYFORTIC (MYCOPHENOLIC ACID) TABLET, DELAYED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0385MYFORTIC (MYCOPHENOLIC ACID) TABLET, DELAYED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]33Current NDC, Legacy NDC, 1 package rows20250503_eed26501-890d-4ff6-88e7-6dbea4726e53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485020mycophenolic acid 180 MG Delayed Release Oral TabletPSNeed26501-890d-4ff6-88e7-6dbea4726e5335
485023mycophenolic acid 360 MG Delayed Release Oral TabletPSNeed26501-890d-4ff6-88e7-6dbea4726e5335
616450Myfortic 180 MG Delayed Release Oral TabletPSNeed26501-890d-4ff6-88e7-6dbea4726e5335
616449Myfortic 360 MG Delayed Release Oral TabletPSNeed26501-890d-4ff6-88e7-6dbea4726e5335
616450mycophenolic acid 180 MG Delayed Release Oral Tablet [Myfortic]SBDeed26501-890d-4ff6-88e7-6dbea4726e5335
616449mycophenolic acid 360 MG Delayed Release Oral Tablet [Myfortic]SBDeed26501-890d-4ff6-88e7-6dbea4726e5335
485020mycophenolic acid 180 MG Delayed Release Oral TabletSCDeed26501-890d-4ff6-88e7-6dbea4726e5335
485023mycophenolic acid 360 MG Delayed Release Oral TabletSCDeed26501-890d-4ff6-88e7-6dbea4726e5335
485020mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral TabletSYeed26501-890d-4ff6-88e7-6dbea4726e5335
485023mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral TabletSYeed26501-890d-4ff6-88e7-6dbea4726e5335
616450Myfortic 180 MG Delayed Release Oral TabletSYeed26501-890d-4ff6-88e7-6dbea4726e5335
616449Myfortic 360 MG Delayed Release Oral TabletSYeed26501-890d-4ff6-88e7-6dbea4726e5335

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0078-0385-6600078038566120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0385-66) 2004-02-270000-00-00NoNoCurrent