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 KIT
Manufacturer
AbbVie Inc.

Identifiers & Regulatory

Product NDC 0074-0579
Product ID 0074-0579_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 00740579
Hyphenated Format 0074-0579

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: label

Resolved Composition

Strengths
  • 10 mg
  • 50 mg
  • 100 mg
  • 07 unit
  • 11 unit
source: label
Packaging
  • 1 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 PACK
source: ndc

Packages (1)

0074-0579-28 1 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 PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Venclexta ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"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 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 PACK", "package_ndc": "0074-0579-28", "marketing_start_date": "20160411"}], "brand_name": "Venclexta", "product_id": "0074-0579_17e6122b-5023-41a7-8b94-d2bdcee1a909", "dosage_form": "KIT", "product_ndc": "0074-0579", "generic_name": "Venetoclax", "labeler_name": "AbbVie Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Venclexta", "application_number": "NDA208573", "marketing_category": "NDA", "marketing_start_date": "20160411", "listing_expiration_date": "20271231"}