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United States · US · US:81520-200_cf9b3216-c9d6-4673-8693-b1ba3273c11d

VOQUEZNA

Orange BookUNIISPLATC A02BC08

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

Identification

ManufacturerPhathom Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA02BC08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8152020030
    30 TABLET in 1 BOTTLE, PLASTIC (81520-200-30)

Annotations

UNII (FDA Substance ID)
4QW3X4AMLB
VONOPRAZAN FUMARATE
RxCUI 2604576
Orange Book
N215151
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4QW3X4AMLB",
    "rxcui": "2604576",
    "inchikey": "ROGSHYHKHPCCJW-WLHGVMLRSA-N",
    "display_name": "VONOPRAZAN FUMARATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "81520-200_cf9b3216-c9d6-4673-8693-b1ba3273c11d",
  "productndc": "81520-200",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "215151",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Nov 1, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Nov 1, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VONOPRAZAN FUMARATE",
  "proprietary_name": "VOQUEZNA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA215151",
  "marketing_category": "NDA",
  "nonproprietary_name": "vonoprazan fumarate",
  "start_marketing_date": "20231110",
  "active_numerator_strength": "26.72"
}

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