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United States · US · US:63304-583_3397d9ea-26ac-a592-e063-6394a90ae937
Fosamprenavir Calcium
Orange BookUNIISPLATC J05AE07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeJ05AE07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116330458301100 TABLET, COATED in 1 BOTTLE (63304-583-01)
- ndc11633045833030 TABLET, COATED in 1 BOTTLE (63304-583-30)
- ndc11633045836060 TABLET, COATED in 1 BOTTLE (63304-583-60)
Annotations
UNII (FDA Substance ID)
ID1GU2627N
FOSAMPRENAVIR CALCIUM
RxCUI 402365
Orange Book
A204024
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": "63304-583_3397d9ea-26ac-a592-e063-6394a90ae937",
"productndc": "63304-583",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "204024",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 700MG BASE",
"product_no": "001",
"approval_date": "Nov 20, 2019"
}
],
"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": "ANDA204024",
"marketing_category": "ANDA",
"nonproprietary_name": "Fosamprenavir Calcium",
"start_marketing_date": "20191128",
"active_numerator_strength": "700"
}Related drugs
Other records sharing ATC code J05AE07.
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