ZOLINZA

Product NDC
0006-0568
11-digit product format
000060568
Labeler code
0006
Product ID
0006-0568_27d99e44-bbc6-445d-b08b-e32fd8702dc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vorinostat
Dosage form
CAPSULE
Route
ORAL
Labeler
Merck Sharp & Dohme LLC
Application
NDA021991
Marketing category
NDA
Marketing start
2006-10-06
Substance
VORINOSTAT
Active strength
100 mg/1
Pharmacologic classes
Histone Deacetylase Inhibitor [EPC], Histone Deacetylase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZOLINZA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VORINOSTAT100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii58IFB293JI
Rxcui668579, 668606

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7e45eb7-08a5-2a3a-66d7-74a79fd3f15aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-0568-40ZOLINZA120 in 1 BOTTLECAPSULE12027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-0568-40EA - Each0006-05680bba8715-c9d9-4e95-83e9-77886c9e0ea212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VORINOSTATACTIVE INGREDIENT58IFB293JIZOLINZA (VORINOSTAT) CAPSULE [MERCK SHARP & DOHME CORP.]14
VORINOSTATACTIVE MOIETY58IFB293JIZOLINZA (VORINOSTAT) CAPSULE [MERCK SHARP & DOHME CORP.]14
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZOLINZA (VORINOSTAT) CAPSULE [MERCK SHARP & DOHME CORP.]14
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ZOLINZA (VORINOSTAT) CAPSULE [MERCK SHARP & DOHME CORP.]14
GELATININACTIVE INGREDIENT2G86QN327LZOLINZA (VORINOSTAT) CAPSULE [MERCK SHARP & DOHME CORP.]14
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLINZA (VORINOSTAT) CAPSULE [MERCK SHARP & DOHME CORP.]14
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JZOLINZA (VORINOSTAT) CAPSULE [MERCK SHARP & DOHME CORP.]14
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLINZA (VORINOSTAT) CAPSULE [MERCK SHARP & DOHME CORP.]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-0568ZOLINZA (VORINOSTAT) CAPSULE [MERCK SHARP & DOHME LLC]26Current NDC, Legacy NDC, 1 package rows20241129_cd86ee78-2781-468b-930c-3c4677bcc092.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
668579vorinostat 100 MG Oral CapsulePSNcd86ee78-2781-468b-930c-3c4677bcc09227
668606Zolinza 100 MG Oral CapsulePSNcd86ee78-2781-468b-930c-3c4677bcc09227
668606vorinostat 100 MG Oral Capsule [Zolinza]SBDcd86ee78-2781-468b-930c-3c4677bcc09227
668579vorinostat 100 MG Oral CapsuleSCDcd86ee78-2781-468b-930c-3c4677bcc09227
668606Zolinza 100 MG Oral CapsuleSYcd86ee78-2781-468b-930c-3c4677bcc09227

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-0568-4000006056840120 CAPSULE in 1 BOTTLE (0006-0568-40) 120 capsule2006-10-060000-00-00NoNoCurrent