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United States · US · US:81520-250_5acd62cf-6c95-479f-9cab-22febc716a4f

VOQUEZNA DUAL PAK

Orange BookSPL

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

Identification

ManufacturerPhathom Pharmaceuticals Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8152025014
    14 BLISTER PACK in 1 CARTON (81520-250-14) / 1 KIT in 1 BLISTER PACK (81520-250-01)

Annotations

Orange Book
N215153
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "0cc52ac5-77ec-4d66-a770-762a1a960914": {
      "match": "brand_token",
      "title": "VOQUEZNA (VONOPRAZAN FUMARATE) TABLET [PHATHOM PHARMACEUTICALS INC.]",
      "spl_version": "5",
      "published_date": "2025-12-23"
    }
  },
  "productid": "81520-250_5acd62cf-6c95-479f-9cab-22febc716a4f",
  "productndc": "81520-250",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "215153",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "500MG;EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "May 3, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "VOQUEZNA DUAL PAK",
  "active_ingred_unit": null,
  "application_number": "NDA215153",
  "marketing_category": "NDA",
  "nonproprietary_name": "vonoprazan fumarate and amoxicillin",
  "start_marketing_date": "20231108",
  "active_numerator_strength": null
}

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