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United States · US · US:0378-3520_88dccf91-6e62-4f5f-849d-1ffa8bf8df9d
Fosamprenavir Calcium
Orange BookUNIISPLATC J05AE07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ05AE07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11037835209160 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3520-91)
Annotations
UNII (FDA Substance ID)
ID1GU2627N
FOSAMPRENAVIR CALCIUM
RxCUI 402365
Orange Book
A204060
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "ID1GU2627N",
"rxcui": "402365",
"inchikey": "PMDQGYMGQKTCSX-HQROKSDRSA-L",
"display_name": "FOSAMPRENAVIR CALCIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"5cd1eead-9fc1-426c-bee8-214ffa7d9dc1": {
"match": "brand_token",
"title": "FOSAMPRENAVIR CALCIUM TABLET, COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
"spl_version": "10",
"published_date": "2025-04-28"
}
},
"productid": "0378-3520_88dccf91-6e62-4f5f-849d-1ffa8bf8df9d",
"productndc": "0378-3520",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "204060",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "EQ 700MG BASE",
"product_no": "001",
"approval_date": "Apr 15, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FOSAMPRENAVIR CALCIUM",
"proprietary_name": "Fosamprenavir Calcium",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204060",
"marketing_category": "ANDA",
"nonproprietary_name": "fosamprenavir calcium",
"start_marketing_date": "20170918",
"active_numerator_strength": "700"
}Related drugs
Other records sharing ATC code J05AE07.
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