fosamprenavir calcium

Generic: fosamprenavir calcium

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fosamprenavir calcium
Generic Name fosamprenavir calcium
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fosamprenavir calcium 700 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-3520
Product ID 0378-3520_88dccf91-6e62-4f5f-849d-1ffa8bf8df9d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204060
Listing Expiration 2026-12-31
Marketing Start 2017-09-18

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 03783520
Hyphenated Format 0378-3520

Supplemental Identifiers

RxCUI
402109
UPC
0303783520919
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 ANDA204060 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 700 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3520-91)
source: ndc

Packages (1)

0378-3520-91 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3520-91)

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": "88dccf91-6e62-4f5f-849d-1ffa8bf8df9d", "openfda": {"upc": ["0303783520919"], "unii": ["ID1GU2627N"], "rxcui": ["402109"], "spl_set_id": ["3a1424d8-844c-4e24-9ebd-b2c2b61b61a3"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3520-91)", "package_ndc": "0378-3520-91", "marketing_start_date": "20170918"}], "brand_name": "Fosamprenavir Calcium", "product_id": "0378-3520_88dccf91-6e62-4f5f-849d-1ffa8bf8df9d", "dosage_form": "TABLET, FILM 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": "0378-3520", "generic_name": "fosamprenavir calcium", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fosamprenavir Calcium", "active_ingredients": [{"name": "FOSAMPRENAVIR CALCIUM", "strength": "700 mg/1"}], "application_number": "ANDA204060", "marketing_category": "ANDA", "marketing_start_date": "20170918", "listing_expiration_date": "20261231"}