NDC 53808-0773

PREZISTA

Darunavir Ethanolate

PREZISTA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by State Of Florida Doh Central Pharmacy. The primary component is Darunavir Ethanolate.

• Product ID: 53808-0773_293699e1-d0c8-4d54-b360-e76b26b7da68
• NDC: 53808-0773
• Product Type: Human Prescription Drug
• Proprietary Name: PREZISTA
• Generic Name: Darunavir Ethanolate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2009-07-01
• Marketing Category: NDA / NDA
• Application Number: NDA021976
• Labeler Name: State of Florida DOH Central Pharmacy
• Substance Name: DARUNAVIR ETHANOLATE
• Active Ingredient Strength: 600 mg/1
• Pharm Classes: HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 53808-0773-1

30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0773-1)

• Marketing Start Date: 2009-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53808-0773-1 [53808077301]

PREZISTA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021976
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-01

Drug Details

Active Ingredients

Ingredient	Strength
DARUNAVIR ETHANOLATE	600 mg/1

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 Ethanolate"

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