AVGEMSI

In shortageOrange BookUNIISPLATC L01BC05

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

Identification

ManufacturerAvyxa Pharma, LLC

CountryUS (United States)

ATC codeL01BC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8383112401
1 VIAL, MULTI-DOSE in 1 CARTON (83831-124-01) / 52.6 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)

U347PV74IL

GEMCITABINE HYDROCHLORIDE

RxCUI 236234

Orange Book

N219920

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Gemcitabine Hydrochloride Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "U347PV74IL",
    "rxcui": "236234",
    "inchikey": "OKKDEIYWILRZIA-OSZBKLCCSA-N",
    "display_name": "GEMCITABINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "e11eeff7-bcaf-4bf1-8da8-88138e01af84": {
      "match": "brand_token",
      "title": "AVGEMSI (GEMCITABINE) INJECTION, SOLUTION [AVYXA PHARMA, LLC]",
      "spl_version": "3",
      "published_date": "2025-08-07"
    }
  },
  "productid": "83831-124_303c41a6-c142-4cd2-b133-9e610845d5bf",
  "productndc": "83831-124",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "219920",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Jun 27, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1GM BASE/26.3ML (EQ 38MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Jun 27, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2GM BASE/52.6ML (EQ 38MG BASE/ML)",
        "product_no": "003",
        "approval_date": "Jun 27, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GEMCITABINE HYDROCHLORIDE",
  "shortage_reason": "Gemcitabine Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "AVGEMSI",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA219920",
  "marketing_category": "NDA",
  "nonproprietary_name": "Gemcitabine",
  "start_marketing_date": "20250803",
  "active_numerator_strength": "38"
}

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