GEMCITABINE

In shortageOrange BookUNIISPLATC L01BC05

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

Identification

ManufacturerHospira, Inc.

CountryUS (United States)

ATC codeL01BC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0409018701
1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0187-01) / 50 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

U347PV74IL

GEMCITABINE HYDROCHLORIDE

RxCUI 236234

Orange Book

A079183

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": "0409-0187_9788e02c-b92a-4ec3-a747-1574a3a76918",
  "productndc": "0409-0187",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "079183",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 2GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "Nov 15, 2010"
      }
    ],
    "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": "mg/mL",
  "application_number": "ANDA079183",
  "marketing_category": "ANDA",
  "nonproprietary_name": "GEMCITABINE",
  "start_marketing_date": "20101115",
  "active_numerator_strength": "38"
}

Related drugs

Other records sharing ATC code L01BC05.

Access this data programmatically

Query GEMCITABINE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs