NDC 70518-0689

PREZISTA

Darunavir

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

• Product ID: 70518-0689_6818b4b6-ba19-d852-e053-2991aa0a87c3
• NDC: 70518-0689
• Product Type: Human Prescription Drug
• Proprietary Name: PREZISTA
• Generic Name: Darunavir
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-08-21
• Marketing Category: NDA / NDA
• Application Number: NDA021976
• Labeler Name: REMEDYREPACK INC.
• 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: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 70518-0689-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0689-0)

• Marketing Start Date: 2017-08-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-0689-0 [70518068900]

PREZISTA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021976
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-08-21
• Marketing End Date: 2020-05-01
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-05-01

Drug Details

Active Ingredients

Ingredient	Strength
DARUNAVIR ETHANOLATE	600 mg/1

OpenFDA Data

• SPL SET ID: 1ba3f528-4d46-4cb4-ba3e-103e01d79573
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • 33O78XF0BW
• RxNorm Concept Unique ID - RxCUI:
  • 794610
  • 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