Myfortic

Product NDC
0078-0386
11-digit product format
000780386
Labeler code
0078
Product ID
0078-0386_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
360 mg/1
Pharmacologic classes
Antimetabolite Immunosuppressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050791-001MYFORTICMYCOPHENOLATE SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALABRLD2004-02-27
N050791-002MYFORTICMYCOPHENOLATE SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALABRLD, RS2004-02-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N050791-001AB
N050791-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N050791-001MYFORTICEQ 180MG BASETABLET, DELAYED RELEASE / ORALABRLD2004-02-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050791-002MYFORTICEQ 360MG BASETABLET, DELAYED RELEASE / ORALABRLD, RS2004-02-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050791-001MYFORTICEQ 180MG BASETABLET, DELAYED RELEASE / ORALABRLD2004-02-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050791-002MYFORTICEQ 360MG BASETABLET, DELAYED RELEASE / ORALABRLD, RS2004-02-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N050791-001MYFORTICEQ 180MG BASETABLET, DELAYED RELEASE / ORALABRLD2004-02-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050791-002MYFORTICEQ 360MG BASETABLET, DELAYED RELEASE / ORALABRLD, RS2004-02-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050791-001MYFORTICEQ 180MG BASETABLET, DELAYED RELEASE / ORALABRLD2004-02-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050791-002MYFORTICEQ 360MG BASETABLET, DELAYED RELEASE / ORALABRLD, RS2004-02-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050791-001MYFORTICEQ 180MG BASETABLET, DELAYED RELEASE / ORALABRLD2004-02-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050791-002MYFORTICEQ 360MG BASETABLET, DELAYED RELEASE / ORALABRLD, RS2004-02-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050791-001MYFORTICEQ 180MG BASETABLET, DELAYED RELEASE / ORALABRLD2004-02-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050791-002MYFORTICEQ 360MG BASETABLET, DELAYED RELEASE / ORALABRLD, RS2004-02-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050791-001MYFORTICEQ 180MG BASETABLET, DELAYED RELEASE / ORALABRLD2004-02-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050791-002MYFORTICEQ 360MG BASETABLET, DELAYED RELEASE / ORALABRLD, RS2004-02-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050791-001MYFORTICEQ 180MG BASETABLET, DELAYED RELEASE / ORALABRLD2004-02-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050791-002MYFORTICEQ 360MG BASETABLET, DELAYED RELEASE / ORALABRLD, RS2004-02-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050791-001MYFORTICEQ 180MG BASETABLET, DELAYED RELEASE / ORALABRLD2004-02-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050791-002MYFORTICEQ 360MG BASETABLET, DELAYED RELEASE / ORALABRLD, RS2004-02-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050791-001MYFORTICEQ 180MG BASETABLET, DELAYED RELEASE / ORALABRLD2004-02-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N050791-002MYFORTICEQ 360MG BASETABLET, DELAYED RELEASE / ORALABRLD, RS2004-02-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050791-001MYFORTICEQ 180MG BASETABLET, DELAYED RELEASE / ORALABRLD2004-02-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050791-002MYFORTICEQ 360MG BASETABLET, DELAYED RELEASE / ORALABRLD, RS2004-02-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050791-001MYFORTICEQ 180MG BASETABLET, DELAYED RELEASE / ORALABRLD2004-02-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050791-002MYFORTICEQ 360MG BASETABLET, DELAYED RELEASE / ORALABRLD, RS2004-02-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050791-001MYFORTICEQ 180MG BASETABLET, DELAYED RELEASE / ORALABRLD2004-02-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050791-002MYFORTICEQ 360MG BASETABLET, DELAYED RELEASE / ORALABRLD, RS2004-02-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050791-001MYFORTICEQ 180MG BASETABLET, DELAYED RELEASE / ORALABRLD2004-02-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050791-002MYFORTICEQ 360MG BASETABLET, DELAYED RELEASE / ORALABRLD, RS2004-02-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050791-001MYFORTICEQ 180MG BASETABLET, DELAYED RELEASE / ORALABRLD2004-02-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050791-002MYFORTICEQ 360MG BASETABLET, DELAYED RELEASE / ORALABRLD, RS2004-02-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050791-001MYFORTICEQ 180MG BASETABLET, DELAYED RELEASE / ORALABRLD2004-02-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050791-002MYFORTICEQ 360MG BASETABLET, DELAYED RELEASE / ORALABRLD, RS2004-02-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050791-001MYFORTICEQ 180MG BASETABLET, DELAYED RELEASE / ORALABRLD2004-02-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050791-002MYFORTICEQ 360MG BASETABLET, DELAYED RELEASE / ORALABRLD, RS2004-02-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050791-001MYFORTIC180MGTABLET, DELAYED RELEASE / ORALABRLD2004-02-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050791-002MYFORTIC360MGTABLET, DELAYED RELEASE / ORALABRLD, RS2004-02-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050791-001MYFORTICEQ 180MG BASETABLET, DELAYED RELEASE / ORALABRLD2004-02-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050791-002MYFORTICEQ 360MG BASETABLET, DELAYED RELEASE / ORALABRLD, RS2004-02-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050791-001MYFORTICEQ 180MG BASETABLET, DELAYED RELEASE / ORALABRLD2004-02-27782e0a99824c…
2021-12-28 21:50 UTC2021-12N050791-002MYFORTICEQ 360MG BASETABLET, DELAYED RELEASE / ORALABRLD, RS2004-02-27782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N050791-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050791-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050791-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050791-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050791-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050791-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050791-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050791-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050791-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050791-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050791-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050791-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050791-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050791-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050791-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050791-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050791-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050791-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050791-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N050791-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050791-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050791-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050791-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050791-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050791-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050791-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050791-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050791-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050791-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050791-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050791-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050791-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050791-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050791-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050791-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050791-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050791-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050791-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050791-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N050791-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Myfortic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MYCOPHENOLATE SODIUM360 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WX877SQI1GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
485020Internal RxNorm lookup
485023Internal RxNorm lookup
616449Internal RxNorm lookup
616450Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
eed26501-890d-4ff6-88e7-6dbea4726e53Available on FDA.report

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
0078-0386-66Myfortic120 in 1 BOTTLETABLET, DELAYED RELEASE12035

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0386-66EA - Each0078-0386f1fe1684-896e-4201-8e60-c33d16fba3a712012-07-24

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
0078-0386MYFORTIC (MYCOPHENOLIC ACID) TABLET, DELAYED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]33Current NDC, Legacy NDC, 1 package rows20250503_eed26501-890d-4ff6-88e7-6dbea4726e53.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MyforticMYCOPHENOLIC ACIDNovartis Pharmaceuticals Corporationeed26501-890d-4ff6-88e7-6dbea4726e532025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 050791
application number: NDA050791
ndc (product): 0078-0386

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
0078-0386-6600078038666120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0386-66) 2004-02-270000-00-00NoNoCurrent