venclexta

Generic: venetoclax

Labeler: abbvie inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name venclexta
Generic Name venetoclax
Labeler abbvie inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

venetoclax 10 mg/1

Manufacturer
AbbVie Inc.

Identifiers & Regulatory

Product NDC 0074-0561
Product ID 0074-0561_17e6122b-5023-41a7-8b94-d2bdcee1a909
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208573
Listing Expiration 2027-12-31
Marketing Start 2016-04-11

Pharmacologic Class

Established (EPC)
bcl-2 inhibitor [epc]
Mechanism of Action
p-glycoprotein inhibitors [moa]
Physiologic Effect
increased cellular death [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00740561
Hyphenated Format 0074-0561

Supplemental Identifiers

RxCUI
1747561 1747567 1747572 1747574 1747575 1747577 1747579 1747580
UNII
N54AIC43PW
NUI
N0000192515 N0000009176 N0000185503

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name venclexta (source: ndc)
Generic Name venetoclax (source: ndc)
Application Number NDA208573 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (0074-0561-11) / 2 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (0074-0561-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

0074-0561-11 1 BLISTER PACK in 1 CARTON (0074-0561-11) / 2 TABLET, FILM COATED in 1 BLISTER PACK 0074-0561-14 1 BLISTER PACK in 1 CARTON (0074-0561-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

venetoclax (10 mg/1)

Linked Drug Pages (1)

Venclexta ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "17e6122b-5023-41a7-8b94-d2bdcee1a909", "openfda": {"nui": ["N0000192515", "N0000009176", "N0000185503"], "unii": ["N54AIC43PW"], "rxcui": ["1747561", "1747567", "1747572", "1747574", "1747575", "1747577", "1747579", "1747580"], "spl_set_id": ["b118a40d-6b56-cee3-10f6-ded821a97018"], "pharm_class_pe": ["Increased Cellular Death [PE]"], "pharm_class_epc": ["BCL-2 Inhibitor [EPC]"], "pharm_class_moa": ["P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["AbbVie Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0074-0561-11)  / 2 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0074-0561-11", "marketing_start_date": "20160411"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0074-0561-14)  / 14 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0074-0561-14", "marketing_start_date": "20160411"}], "brand_name": "Venclexta", "product_id": "0074-0561_17e6122b-5023-41a7-8b94-d2bdcee1a909", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["BCL-2 Inhibitor [EPC]", "Increased Cellular Death [PE]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "0074-0561", "generic_name": "Venetoclax", "labeler_name": "AbbVie Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Venclexta", "active_ingredients": [{"name": "VENETOCLAX", "strength": "10 mg/1"}], "application_number": "NDA208573", "marketing_category": "NDA", "marketing_start_date": "20160411", "listing_expiration_date": "20271231"}