NDC 0074-0576

Venclexta

Venetoclax

Venclexta is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Abbvie Inc.. The primary component is Venetoclax.

• Product ID: 0074-0576_2284c7ad-cd64-4d4c-0355-1e21172bba43
• NDC: 0074-0576
• Product Type: Human Prescription Drug
• Proprietary Name: Venclexta
• Generic Name: Venetoclax
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-04-11
• Marketing Category: NDA / NDA
• Application Number: NDA208573
• Labeler Name: AbbVie Inc.
• Substance Name: VENETOCLAX
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: BCL-2 Inhibitor [EPC],Increased Cellular Death [PE],P-Glycoprotein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0074-0576-11

1 BLISTER PACK in 1 CARTON (0074-0576-11) > 1 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2016-04-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0074-0576-11 [00074057611]

Venclexta TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA208573
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-04-11

NDC 0074-0576-22 [00074057622]

Venclexta TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA208573
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-04-11

NDC 0074-0576-34 [00074057634]

Venclexta TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA208573
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-11-21

Drug Details

Active Ingredients

Ingredient	Strength
VENETOCLAX	100 mg/1

OpenFDA Data

• SPL SET ID: b118a40d-6b56-cee3-10f6-ded821a97018
• Manufacturer:
  • AbbVie Inc.
• UNII:
  • N54AIC43PW
• RxNorm Concept Unique ID - RxCUI:
  • 1747579
  • 1747580
  • 1747572
  • 1747567
  • 1747561
  • 1747577
  • 1747574
  • 1747575
• UPC Code:
  • 0300740576224

Pharmacological Class

• BCL-2 Inhibitor [EPC]
• Increased Cellular Death [PE]
• P-Glycoprotein Inhibitors [MoA]

NDC Crossover Matching brand name "Venclexta" or generic name "Venetoclax"

NDC	Brand Name	Generic Name
0074-0561	Venclexta	Venetoclax
0074-0566	Venclexta	Venetoclax
0074-0576	Venclexta	Venetoclax
0074-0579	Venclexta	Venetoclax