fosamprenavir calcium

Generic: fosamprenavir calcium

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fosamprenavir calcium
Generic Name fosamprenavir calcium
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

fosamprenavir calcium 700 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 63304-583
Product ID 63304-583_3397d9ea-26ac-a592-e063-6394a90ae937
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204024
Listing Expiration 2026-12-31
Marketing Start 2019-11-28

Pharmacologic Class

Classes
cytochrome p450 3a4 inducers [moa] cytochrome p450 3a4 inhibitors [moa] hiv protease inhibitors [moa] p-glycoprotein inducers [moa] protease inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63304583
Hyphenated Format 63304-583

Supplemental Identifiers

RxCUI
402109
UNII
ID1GU2627N

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fosamprenavir calcium (source: ndc)
Generic Name fosamprenavir calcium (source: ndc)
Application Number ANDA204024 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 700 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (63304-583-01)
  • 30 TABLET, COATED in 1 BOTTLE (63304-583-30)
  • 60 TABLET, COATED in 1 BOTTLE (63304-583-60)
source: ndc

Packages (3)

63304-583-01 100 TABLET, COATED in 1 BOTTLE (63304-583-01) 63304-583-30 30 TABLET, COATED in 1 BOTTLE (63304-583-30) 63304-583-60 60 TABLET, COATED in 1 BOTTLE (63304-583-60)

Ingredients (1)

fosamprenavir calcium (700 mg/1)

Linked Drug Pages (1)

Fosamprenavir Calcium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3397d9ea-26ac-a592-e063-6394a90ae937", "openfda": {"unii": ["ID1GU2627N"], "rxcui": ["402109"], "spl_set_id": ["5cd1eead-9fc1-426c-bee8-214ffa7d9dc1"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (63304-583-01)", "package_ndc": "63304-583-01", "marketing_start_date": "20191128"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (63304-583-30)", "package_ndc": "63304-583-30", "marketing_start_date": "20191128"}, {"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (63304-583-60)", "package_ndc": "63304-583-60", "marketing_start_date": "20191128"}], "brand_name": "Fosamprenavir Calcium", "product_id": "63304-583_3397d9ea-26ac-a592-e063-6394a90ae937", "dosage_form": "TABLET, COATED", "pharm_class": ["Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "HIV Protease Inhibitors [MoA]", "P-Glycoprotein Inducers [MoA]", "Protease Inhibitor [EPC]"], "product_ndc": "63304-583", "generic_name": "Fosamprenavir Calcium", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fosamprenavir Calcium", "active_ingredients": [{"name": "FOSAMPRENAVIR CALCIUM", "strength": "700 mg/1"}], "application_number": "ANDA204024", "marketing_category": "ANDA", "marketing_start_date": "20191128", "listing_expiration_date": "20261231"}