NDC 53808-0809

Viracept

Nelfinavir Mesylate

Viracept 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 Nelfinavir Mesylate.

• Product ID: 53808-0809_d93799ad-308b-4f54-b8d5-07402cd8882e
• NDC: 53808-0809
• Product Type: Human Prescription Drug
• Proprietary Name: Viracept
• Generic Name: Nelfinavir Mesylate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2009-07-01
• Marketing Category: NDA / NDA
• Application Number: NDA021503
• Labeler Name: State of Florida DOH Central Pharmacy
• Substance Name: NELFINAVIR MESYLATE
• Active Ingredient Strength: 625 mg/1
• Pharm Classes: HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 53808-0809-1

30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0809-1)

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

NDC SPL Data Element Entries

NDC 53808-0809-1 [53808080901]

Viracept TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021503
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
NELFINAVIR MESYLATE	625 mg/1

OpenFDA Data

• SPL SET ID: 9b370904-d2cd-4585-bc48-a8110621c8bd
• Manufacturer:
  • State of Florida DOH Central Pharmacy
• UNII:
  • 98D603VP8V
• RxNorm Concept Unique ID - RxCUI:
  • 542370
  • 403978
• UPC Code:
  • 0363010027703

Pharmacological Class

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

NDC Crossover Matching brand name "Viracept" or generic name "Nelfinavir Mesylate"

NDC	Brand Name	Generic Name
52959-289	VIRACEPT	nelfinavir mesylate
53808-0809	Viracept	NELFINAVIR MESYLATE
55289-477	VIRACEPT	nelfinavir mesylate
63010-010	VIRACEPT	nelfinavir mesylate
63010-027	VIRACEPT	nelfinavir mesylate