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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

  • ndc11
    6330458301
    100 TABLET, COATED in 1 BOTTLE (63304-583-01)
  • ndc11
    6330458330
    30 TABLET, COATED in 1 BOTTLE (63304-583-30)
  • ndc11
    6330458360
    60 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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