Gemcitabine

In shortageOrange BookUNIISPLATC L01BC05

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

Identification

ManufacturerMeitheal Pharmaceuticals Inc.

CountryUS (United States)

ATC codeL01BC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
7128811706
1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-06) / 5.26 mL in 1 VIAL, SINGLE-DOSE
ndc11
7128811728
1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-28) / 26.3 mL in 1 VIAL, SINGLE-DOSE
ndc11
7128811754
1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-54) / 52.6 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

U347PV74IL

GEMCITABINE HYDROCHLORIDE

RxCUI 236234

Orange Book

A212129

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": "71288-117_c5bbcd6c-28a2-4db0-86dd-4c9ce60a434f",
  "productndc": "71288-117",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "212129",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "200MG/5.26ML (38MG/ML)",
        "product_no": "001",
        "approval_date": "Dec 11, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1GM/26.3ML (38MG/ML)",
        "product_no": "002",
        "approval_date": "Dec 11, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2GM/52.6ML (38MG/ML)",
        "product_no": "003",
        "approval_date": "Dec 11, 2020"
      }
    ],
    "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": "ANDA212129",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gemcitabine hydrochloride",
  "start_marketing_date": "20201211",
  "active_numerator_strength": "38"
}

Related drugs

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