NDC 59676-563

PREZISTA

Darunavir

PREZISTA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Janssen Products Lp. The primary component is Darunavir Ethanolate.

• Product ID: 59676-563_04a6e608-8107-11eb-8ef7-26defb2ca371
• NDC: 59676-563
• Product Type: Human Prescription Drug
• Proprietary Name: PREZISTA
• Generic Name: Darunavir
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2009-01-14
• Marketing Category: NDA / NDA
• Application Number: NDA021976
• Labeler Name: Janssen Products LP
• Substance Name: DARUNAVIR ETHANOLATE
• Active Ingredient Strength: 75 mg/1
• Pharm Classes: HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 59676-563-01

480 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59676-563-01)

• Marketing Start Date: 2009-01-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59676-563-01 [59676056301]

PREZISTA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021976
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-01-14

Drug Details

Active Ingredients

Ingredient	Strength
DARUNAVIR ETHANOLATE	75 mg/1

OpenFDA Data

• SPL SET ID: 814301f9-c990-46a5-b481-2879a521a16f
• Manufacturer:
  • Janssen Products LP
• UNII:
  • 33O78XF0BW
• RxNorm Concept Unique ID - RxCUI:
  • 1359271
  • 831868
  • 1236628
  • 1236632
  • 831870
  • 794610
  • 850455
  • 850457
  • 1359269
  • 670026

Pharmacological Class

• HIV Protease Inhibitors [MoA]
• Protease Inhibitor [EPC]
• Cytochrome P450 3A Inhibitors [MoA]
• Cytochrome P450 2D6 Inhibitors [MoA]

NDC Crossover Matching brand name "PREZISTA" or generic name "Darunavir"

NDC	Brand Name	Generic Name
50090-1327	PREZISTA	darunavir
50090-1491	PREZISTA	darunavir
53808-0672	PREZISTA	darunavir ethanolate
53808-0773	PREZISTA	darunavir ethanolate
59676-562	PREZISTA	darunavir
59676-563	PREZISTA	darunavir
59676-564	PREZISTA	darunavir
59676-565	PREZISTA	darunavir
70518-0689	PREZISTA	PREZISTA
70518-1483	PREZISTA	PREZISTA
59676-566	PREZISTA	PREZISTA