GEMCITABINE

In shortageOrange BookUNIISPLATC L01BC05

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeL01BC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6332312594
1 VIAL, SINGLE-DOSE in 1 BOX (63323-125-94) / 25 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

U347PV74IL

GEMCITABINE HYDROCHLORIDE

RxCUI 236234

Orange Book

A090799

APAPAP

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": {
    "dc02a23b-3ff9-4441-aa91-8e9e629a7315": {
      "match": "brand_token",
      "title": "GEMCITABINE INJECTION, SOLUTION [HOSPIRA, INC.]",
      "spl_version": "28",
      "published_date": "2026-04-29"
    }
  },
  "productid": "63323-125_4c447f74-d06c-459b-ba63-6b72aaf4fd2e",
  "productndc": "63323-125",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "090799",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 200MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jul 25, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jul 25, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 2GM BASE/VIAL",
        "product_no": "003",
        "approval_date": "May 16, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GEMCITABINE HYDROCHLORIDE",
  "shortage_reason": "Gemcitabine Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "GEMCITABINE",
  "active_ingred_unit": "g/25mL",
  "application_number": "ANDA090799",
  "marketing_category": "ANDA",
  "nonproprietary_name": "GEMCITABINE",
  "start_marketing_date": "20110726",
  "active_numerator_strength": "1"
}

Related drugs

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