FDA.reportPublic FDA data

Zortress

Product NDC
0078-0422
11-digit product format
000780422
Labeler code
0078
Product ID
0078-0422_5b9ba6f0-1e1d-4b9c-9122-ad856284d7ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
everolimus
Dosage form
TABLET
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA021560
Marketing category
NDA
Marketing start
2010-04-22
Substance
EVEROLIMUS
Active strength
1 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EVEROLIMUS1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9HW64Q8G6G
Rxcui977427, 977431, 977434, 977436, 977438, 977440, 2056895, 2056897

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
807eb842-6749-6eff-f9ce-2751c69fde93Product name420260122
151279ee-9f3c-b884-3327-05b3fa99d863Product name620251027

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0078-0422-202023-08-01C16284748780-10191ceaa-688d-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use ZORTRESS safely and effectively. See full prescribing information for ZORTRESS. ZORTRESS ® (everolimus) tablets, for oral use Initial U.S. Approval: 2010
0078-0422-202023-07-28C16284748780-10191ceaa-688d-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use ZORTRESS safely and effectively. See full prescribing information for ZORTRESS. ZORTRESS ® (everolimus) tablets, for oral use Initial U.S. Approval: 2010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0422-20Zortress60 in 1 BOXTABLET6029
0078-0422-61Zortress1 in 1 BLISTER PACKTABLET129

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0422-20EA - Each0078-04220b14653c-96ac-4c80-9b72-5f58bae0948b12018-11-06
0078-0422-61EA - Each0078-042298ebd157-68eb-470b-91d5-74b5f3c212ac12018-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EVEROLIMUSACTIVE INGREDIENT9HW64Q8G6GZORTRESS (EVEROLIMUS) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]13
EVEROLIMUSACTIVE MOIETY9HW64Q8G6GZORTRESS (EVEROLIMUS) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]13
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKZORTRESS (EVEROLIMUS) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]13
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KZORTRESS (EVEROLIMUS) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]13
CROSPOVIDONEINACTIVE INGREDIENT68401960MKZORTRESS (EVEROLIMUS) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]13
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZORTRESS (EVEROLIMUS) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]13
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZORTRESS (EVEROLIMUS) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZORTRESS (EVEROLIMUS) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0422ZORTRESS (EVEROLIMUS) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]27Current NDC, Legacy NDC, 2 package rows20250105_e082a024-7850-400b-a5c2-2a140612562a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977427everolimus 0.25 MG Oral TabletPSNe082a024-7850-400b-a5c2-2a140612562a29
977434everolimus 0.5 MG Oral TabletPSNe082a024-7850-400b-a5c2-2a140612562a29
977438everolimus 0.75 MG Oral TabletPSNe082a024-7850-400b-a5c2-2a140612562a29
2056895everolimus 1 MG Oral TabletPSNe082a024-7850-400b-a5c2-2a140612562a29
977431Zortress 0.25 MG Oral TabletPSNe082a024-7850-400b-a5c2-2a140612562a29
977436Zortress 0.5 MG Oral TabletPSNe082a024-7850-400b-a5c2-2a140612562a29
977440Zortress 0.75 MG Oral TabletPSNe082a024-7850-400b-a5c2-2a140612562a29
2056897ZORTRESS 1 MG Oral TabletPSNe082a024-7850-400b-a5c2-2a140612562a29
977431everolimus 0.25 MG Oral Tablet [Zortress]SBDe082a024-7850-400b-a5c2-2a140612562a29
977436everolimus 0.5 MG Oral Tablet [Zortress]SBDe082a024-7850-400b-a5c2-2a140612562a29
977440everolimus 0.75 MG Oral Tablet [Zortress]SBDe082a024-7850-400b-a5c2-2a140612562a29
2056897everolimus 1 MG Oral Tablet [Zortress]SBDe082a024-7850-400b-a5c2-2a140612562a29
977427everolimus 0.25 MG Oral TabletSCDe082a024-7850-400b-a5c2-2a140612562a29
977434everolimus 0.5 MG Oral TabletSCDe082a024-7850-400b-a5c2-2a140612562a29
977438everolimus 0.75 MG Oral TabletSCDe082a024-7850-400b-a5c2-2a140612562a29
2056895everolimus 1 MG Oral TabletSCDe082a024-7850-400b-a5c2-2a140612562a29
977434everolimus 500 MCG Oral TabletSYe082a024-7850-400b-a5c2-2a140612562a29
977438everolimus 750 MCG Oral TabletSYe082a024-7850-400b-a5c2-2a140612562a29
977431Zortress 0.25 MG Oral TabletSYe082a024-7850-400b-a5c2-2a140612562a29
977436Zortress 0.5 MG Oral TabletSYe082a024-7850-400b-a5c2-2a140612562a29
977440Zortress 0.75 MG Oral TabletSYe082a024-7850-400b-a5c2-2a140612562a29
2056897Zortress 1 MG Oral TabletSYe082a024-7850-400b-a5c2-2a140612562a29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0422-200007804222060 BLISTER PACK in 1 BOX (0078-0422-20) / 1 TABLET in 1 BLISTER PACK (0078-0422-61) 60 blister pack2018-08-100000-00-00NoNoCurrent
0078-0422-61000780422611 in 1 BLISTER PACKHistorical