NDC 53808-0674

Invirase

Saquinavir Mesylate

Invirase 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 Saquinavir Mesylate.

• Product ID: 53808-0674_e981c067-b7f7-440b-a4d3-1cd79038af4a
• NDC: 53808-0674
• Product Type: Human Prescription Drug
• Proprietary Name: Invirase
• Generic Name: Saquinavir Mesylate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2009-07-01
• Marketing Category: NDA / NDA
• Application Number: NDA021785
• Labeler Name: State of Florida DOH Central Pharmacy
• Substance Name: SAQUINAVIR MESYLATE
• Active Ingredient Strength: 500 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 53808-0674-1

30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0674-1)

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

NDC SPL Data Element Entries

NDC 53808-0674-1 [53808067401]

Invirase TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021785
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
SAQUINAVIR MESYLATE	500 mg/1

OpenFDA Data

• SPL SET ID: b8b53129-06ab-4143-b9b7-7675e49a52ef
• Manufacturer:
  • State of Florida DOH Central Pharmacy
• UNII:
  • UHB9Z3841A
• RxNorm Concept Unique ID - RxCUI:
  • 859865
  • 859863
• UPC Code:
  • 0300040244519

Pharmacological Class

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

NDC Crossover Matching brand name "Invirase" or generic name "Saquinavir Mesylate"

NDC	Brand Name	Generic Name
0004-0244	Invirase	saquinavir mesylate
0004-0245	Invirase	saquinavir mesylate
53808-0674	Invirase	saquinavir mesylate