NDC 63304-583

Fosamprenavir Calcium

Fosamprenavir Calcium

Fosamprenavir Calcium is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Fosamprenavir Calcium.

• Product ID: 63304-583_5d53a971-671a-4ca6-87f8-2a629099eca7
• NDC: 63304-583
• Product Type: Human Prescription Drug
• Proprietary Name: Fosamprenavir Calcium
• Generic Name: Fosamprenavir Calcium
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-11-28
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204024
• Labeler Name: Sun Pharmaceutical Industries, Inc.
• 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: 2020-12-31

Packaging

NDC 63304-583-01

100 TABLET, COATED in 1 BOTTLE (63304-583-01)

• Marketing Start Date: 2019-11-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63304-583-01 [63304058301]

Fosamprenavir Calcium TABLET, COATED

• Marketing Category: ANDA
• Application Number: ANDA204024
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-11-28

NDC 63304-583-30 [63304058330]

Fosamprenavir Calcium TABLET, COATED

• Marketing Category: ANDA
• Application Number: ANDA204024
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-11-28

NDC 63304-583-60 [63304058360]

Fosamprenavir Calcium TABLET, COATED

• Marketing Category: ANDA
• Application Number: ANDA204024
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-11-28

Drug Details

Active Ingredients

Ingredient	Strength
FOSAMPRENAVIR CALCIUM	700 mg/1

Pharmacological Class

• Protease Inhibitor [EPC]
• Cytochrome P450 3A4 Inhibitors [MoA]
• Cytochrome P450 3A4 Inducers [MoA]
• P-Glycoprotein Inducers [MoA]
• HIV Protease Inhibitors [MoA]
• 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 "Fosamprenavir Calcium" or generic name "Fosamprenavir Calcium"

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