Gemcitabine

In shortageOrange BookUNIISPLATC L01BC05

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

Identification

ManufacturerSagent Pharmaceuticals

CountryUS (United States)

ATC codeL01BC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
2502123905
1 VIAL in 1 CARTON (25021-239-05) / 5.26 mL in 1 VIAL
ndc11
2502123926
1 VIAL in 1 CARTON (25021-239-26) / 26.3 mL in 1 VIAL
ndc11
2502123952
1 VIAL in 1 CARTON (25021-239-52) / 52.6 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

U347PV74IL

GEMCITABINE HYDROCHLORIDE

RxCUI 236234

Orange Book

A209077

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": "25021-239_adf9b715-8cef-4a0d-ba30-d948b2b04272",
  "productndc": "25021-239",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "209077",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "200MG/5.26ML (38MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 20, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1GM/26.3ML (38MG/ML)",
        "product_no": "002",
        "approval_date": "Jul 20, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2GM/52.6ML (38MG/ML)",
        "product_no": "003",
        "approval_date": "Jul 20, 2018"
      }
    ],
    "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": "ANDA209077",
  "marketing_category": "ANDA",
  "nonproprietary_name": "gemcitabine",
  "start_marketing_date": "20190115",
  "active_numerator_strength": "38"
}

Related drugs

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