FDA.reportPublic FDA data

Venclexta

Product NDC
0074-0561
11-digit product format
000740561
Labeler code
0074
Product ID
0074-0561_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
10 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
VENETOCLAX10 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
0074-0561-11Venclexta2 in 1 BLISTER PACKTABLET, FILM COATED2282
0074-0561-11Venclexta1 in 1 CARTONTABLET, FILM COATED1282
0074-0561-14Venclexta14 in 1 BLISTER PACKTABLET, FILM COATED14282
0074-0561-14Venclexta1 in 1 CARTONTABLET, FILM COATED1282

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-0561-11EA - Each0074-0561145da4f1-a0c9-421a-9600-c0b20da10afa12016-05-16
0074-0561-14EA - Each0074-05611109b32a-4523-4b1c-8bbf-735ff89182a412016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-0561VENCLEXTA (VENETOCLAX) KIT VENCLEXTA (VENETOCLAX) TABLET, FILM COATED [ABBVIE INC.]276Current NDC, Legacy NDC, 4 package rows20240718_b118a40d-6b56-cee3-10f6-ded821a97018.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0074-0561-11000740561111 BLISTER PACK in 1 CARTON (0074-0561-11) / 2 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2016-04-110000-00-00NoNoCurrent
0074-0561-14000740561141 BLISTER PACK in 1 CARTON (0074-0561-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2016-04-110000-00-00NoNoCurrent