gemcitabine hydrochloride

In shortageOrange BookUNIISPLATC L01BC05

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

Identification

ManufacturerGland Pharma Limited

CountryUS (United States)

ATC codeL01BC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6808314801
1 VIAL in 1 CARTON (68083-148-01) / 5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

U347PV74IL

GEMCITABINE HYDROCHLORIDE

RxCUI 236234

Orange Book

A204520

APAP

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": "68083-148_35c72954-279a-45fe-aa22-2b97e20b7b0d",
  "productndc": "68083-148",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "204520",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 200MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jan 5, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jan 5, 2016"
      }
    ],
    "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 hydrochloride",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA204520",
  "marketing_category": "ANDA",
  "nonproprietary_name": "gemcitabine hydrochloride",
  "start_marketing_date": "20160201",
  "active_numerator_strength": "200"
}

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