VOQUEZNA TRIPLE PAK

Orange BookSPL

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

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
8152025514
14 BLISTER PACK in 1 CARTON (81520-255-14) / 1 KIT in 1 BLISTER PACK (81520-255-01)

Annotations

Orange Book

N215152

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": "81520-255_5acd62cf-6c95-479f-9cab-22febc716a4f",
  "productndc": "81520-255",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "215152",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "500MG;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 TRIPLE PAK",
  "active_ingred_unit": null,
  "application_number": "NDA215152",
  "marketing_category": "NDA",
  "nonproprietary_name": "vonoprazan fumarate, amoxicillin and clarithromycin",
  "start_marketing_date": "20231108",
  "active_numerator_strength": null
}

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