FIRVANQ

Orange BookSPL

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

Identification

ManufacturerAzurity Pharmaceuticals, Inc

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6562820405
1 KIT in 1 CARTON (65628-204-05) * 3.75 g in 1 BOTTLE * 147 mL in 1 BOTTLE

Annotations

Orange Book

N208910

AAAA

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "5aca5508-b577-446c-9980-ab4c7582b4b9": {
      "match": "brand_token",
      "title": "FIRVANQ (VANCOMYCIN HYDROCHLORIDE) KIT [AZURITY PHARMACEUTICALS, INC]",
      "spl_version": "11",
      "published_date": "2025-12-17"
    }
  },
  "productid": "65628-204_4606f496-387d-f0e0-e063-6294a90ad37a",
  "productndc": "65628-204",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "208910",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AA",
        "strength": "EQ 25MG BASE/ML",
        "product_no": "001",
        "approval_date": "Jan 26, 2018"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AA",
        "strength": "EQ 50MG BASE/ML",
        "product_no": "002",
        "approval_date": "Jan 26, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "FIRVANQ",
  "active_ingred_unit": null,
  "application_number": "NDA208910",
  "marketing_category": "NDA",
  "nonproprietary_name": "vancomycin hydrochloride",
  "start_marketing_date": "20180126",
  "active_numerator_strength": null
}

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