Cayston

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerGilead Sciences, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6195809011
2 CARTON in 1 PACKAGE (61958-0901-1) / 1 KIT in 1 CARTON * 1 mL in 1 VIAL * 1 mL in 1 AMPULE

Annotations

Orange Book

N050814

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "67300ca3-8c53-4ce4-8e86-2c03be1f9b8a": {
      "match": "brand_token",
      "title": "CAYSTON (AZTREONAM) KIT [GILEAD SCIENCES, INC.]",
      "spl_version": "14",
      "published_date": "2025-12-22"
    }
  },
  "productid": "61958-0901_1485e37e-2b42-42bf-abb3-dd1241b02449",
  "productndc": "61958-0901",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "050814",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "75MG/VIAL",
        "product_no": "001",
        "approval_date": "Feb 22, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Cayston",
  "active_ingred_unit": null,
  "application_number": "NDA050814",
  "marketing_category": "NDA",
  "nonproprietary_name": "aztreonam",
  "start_marketing_date": "20100222",
  "active_numerator_strength": null
}

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