FDA.reportPublic FDA data

Venclexta

Product NDC
0074-0579
11-digit product format
000740579
Labeler code
0074
Product ID
0074-0579_17e6122b-5023-41a7-8b94-d2bdcee1a909
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venetoclax
Dosage form
KIT
Labeler
AbbVie Inc.
Application
NDA208573
Marketing category
NDA
Marketing start
2016-04-11
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN54AIC43PW
Rxcui1747561, 1747567, 1747572, 1747574, 1747575, 1747577, 1747579, 1747580

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fa4e04f-da16-456f-8bf8-e9049bbf45c3Product name220180806

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0074-0579-28Venclexta1 in 1 CARTONKIT1282

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-0579-28EA - Each0074-05796dc07da0-8a49-4ccc-99a5-73a9c5e7797a12016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-0579VENCLEXTA (VENETOCLAX) KIT VENCLEXTA (VENETOCLAX) TABLET, FILM COATED [ABBVIE INC.]276Current NDC, Legacy NDC, 1 package rows20240718_b118a40d-6b56-cee3-10f6-ded821a97018.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0074-0579-28000740579281 KIT in 1 CARTON (0074-0579-28) * 7 TABLET, FILM COATED in 1 BLISTER PACK * 7 TABLET, FILM COATED in 1 BLISTER PACK * 14 TABLET, FILM COATED in 1 BLISTER PACK * 14 TABLET, FILM COATED in 1 BLISTER PACK1 kit2016-04-110000-00-00NoNoCurrent