Venclexta

Product NDC
0074-0576
11-digit product format
000740576
Labeler code
0074
Product ID
0074-0576_17e6122b-5023-41a7-8b94-d2bdcee1a909
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venetoclax
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AbbVie Inc.
Application
NDA208573
Marketing category
NDA
Marketing start
2016-04-11
Substance
VENETOCLAX
Active strength
100 mg/1
Pharmacologic classes
BCL-2 Inhibitor [EPC], Increased Cellular Death [PE], P-Glycoprotein 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
Venclexta
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENETOCLAX100 mg/1

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
0074-0576-11Venclexta1 in 1 BLISTER PACKTABLET, FILM COATED1282
0074-0576-11Venclexta1 in 1 CARTONTABLET, FILM COATED1282
0074-0576-22Venclexta120 in 1 BOTTLETABLET, FILM COATED120282
0074-0576-30Venclexta1 in 1 CARTONTABLET, FILM COATED1282
0074-0576-30Venclexta28 in 1 BOTTLETABLET, FILM COATED28282
0074-0576-34Venclexta180 in 1 BOTTLETABLET, FILM COATED180282
0074-0576-34Venclexta1 in 1 CARTONTABLET, FILM COATED1282

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-0576-11EA - Each0074-057636cba366-1ddc-4a37-a224-6d747d7d419412016-05-16
0074-0576-22EA - Each0074-0576c0dbf3c2-1418-42b7-b78d-f8b84bd51d8012016-05-16
0074-0576-30EA - Each0074-0576e25ea65d-3e97-48a5-ae2d-ffc888fbfd6612022-10-06
0074-0576-34EA - Each0074-05768bf5bc05-a31d-4aa0-90f6-24616bc0c7a012018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-0576VENCLEXTA (VENETOCLAX) KIT VENCLEXTA (VENETOCLAX) TABLET, FILM COATED [ABBVIE INC.]276Current NDC, Legacy NDC, 7 package rows20240718_b118a40d-6b56-cee3-10f6-ded821a97018.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0074-0576-11000740576111 BLISTER PACK in 1 CARTON (0074-0576-11) / 1 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2016-04-110000-00-00NoNoCurrent
0074-0576-2200074057622120 TABLET, FILM COATED in 1 BOTTLE (0074-0576-22) 2016-04-110000-00-00NoNoCurrent
0074-0576-30000740576301 BOTTLE in 1 CARTON (0074-0576-30) / 28 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-06-150000-00-00NoNoCurrent
0074-0576-34000740576341 BOTTLE in 1 CARTON (0074-0576-34) > 180 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-11-210000-00-00NoNoCurrent