NDC 53808-1010

LEXIVA

Fosamprenavir Calcium

LEXIVA 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 Fosamprenavir Calcium.

• Product ID: 53808-1010_7c778d60-3b61-4b2b-9cf7-1a6b4ad3b7db
• NDC: 53808-1010
• Product Type: Human Prescription Drug
• Proprietary Name: LEXIVA
• Generic Name: Fosamprenavir Calcium
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2014-11-01
• Marketing Category: NDA / NDA
• Application Number: NDA021548
• Labeler Name: State of Florida DOH Central Pharmacy
• Substance Name: FOSAMPRENAVIR CALCIUM
• Active Ingredient Strength: 700 mg/1
• Pharm Classes: Protease Inhibitor [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],P-Glycoprotein Inducers [MoA],HIV Protease Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 53808-1010-1

30 TABLET, FILM COATED in 1 BLISTER PACK (53808-1010-1)

• Marketing Start Date: 2014-11-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53808-1010-1 [53808101001]

LEXIVA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021548
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-11-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
FOSAMPRENAVIR CALCIUM	700 mg/1

OpenFDA Data

• SPL SET ID: b919bb7e-75f8-4df4-924c-54e829be0607
• Manufacturer:
  • State of Florida DOH Central Pharmacy
• UNII:
  • ID1GU2627N
• RxNorm Concept Unique ID - RxCUI:
  • 402109
  • 402110

Pharmacological Class

• Protease Inhibitor [EPC]
• Cytochrome P450 3A4 Inhibitors [MoA]
• Cytochrome P450 3A4 Inducers [MoA]
• P-Glycoprotein Inducers [MoA]
• HIV Protease Inhibitors [MoA]

NDC Crossover Matching brand name "LEXIVA" or generic name "Fosamprenavir Calcium"

NDC	Brand Name	Generic Name
49702-207	LEXIVA	fosamprenavir calcium
49702-208	LEXIVA	fosamprenavir calcium
53808-0281	LEXIVA	fosamprenavir calcium
53808-1010	LEXIVA	fosamprenavir calcium
0378-3520	Fosamprenavir Calcium	fosamprenavir calcium
63304-583	Fosamprenavir Calcium	Fosamprenavir Calcium