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United States · US · US:63010-010_4af6d4ca-b410-48e3-925e-ce23a14db18a

VIRACEPT

Orange BookUNIISPLATC J05AE04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAGOURON
CountryUS (United States)
ATC codeJ05AE04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6301001030
    300 TABLET, FILM COATED in 1 BOTTLE (63010-010-30)

Annotations

UNII (FDA Substance ID)
98D603VP8V
NELFINAVIR MESYLATE
RxCUI 266565
Orange Book
N020779
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "98D603VP8V",
    "rxcui": "266565",
    "inchikey": "NQHXCOAXSHGTIA-SKXNDZRYSA-N",
    "display_name": "NELFINAVIR MESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e72c2bc6-9462-4a2e-8e1d-b97592376cbd": {
      "match": "brand_token",
      "title": "VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED [AGOURON]",
      "spl_version": "35",
      "published_date": "2025-12-12"
    }
  },
  "productid": "63010-010_4af6d4ca-b410-48e3-925e-ce23a14db18a",
  "productndc": "63010-010",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020779",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Mar 14, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NELFINAVIR MESYLATE",
  "proprietary_name": "VIRACEPT",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020779",
  "marketing_category": "NDA",
  "nonproprietary_name": "nelfinavir mesylate",
  "start_marketing_date": "19970314",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code J05AE04.

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