Gemcitabine 38 mg/mL
Gemcitabine · INJECTION, SOLUTION · Hikma Pharmaceuticals USA Inc.
Gemcitabine is a injection, solution containing gemcitabine at 38 mg/mL, taken intravenous. Manufactured by Hikma Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- Gemcitabine
- Generic Name
- Gemcitabine
- NDC Code (Product)
0143-9341- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 38 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA213175
- Marketing Start
- 10/17/2025
Recall History
Edge Pharma, LLC
Lack of Assurance of Sterility
Mylan Institutional LLC
Presence of Particulate Matter
Infusion Options, Inc.
Lack of Assurance of Sterility
Caraco Pharmaceutical Laboratories, Ltd.
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
Mylan Institutional LLC
Presence of Particulate Matter
Mylan Institutional LLC
Presence of Particulate Matter
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: • in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) • in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. ( 1.2 ) • in combination with cisplatin for the treatment of non-small cell lung cancer. ( 1.3 ) • as a single agent for the treatment of pancreatic cancer. ( 1.4 ) 1.1 Ovarian Cancer Gemcitabine Injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. 1.2 Breast Cancer Gemcitabine Injection in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. 1.3 Non-Small Cell Lung Cancer Gemcitabine Injection in…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Gemcitabine Injection is for intravenous use only. • Ovarian Cancer: 1000 mg/m 2 over 30 minutes on Days 1 and 8 of each 21-day cycle. ( 2.1 ) • Breast Cancer: 1250 mg/m 2 over 30 minutes on Days 1 and 8 of each 21-day cycle. ( 2.2 ) • Non-Small Cell Lung Cancer: 1000 mg/m 2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle or 1250 mg/m 2 over 30 minutes on Days 1 and 8 of each 21-day cycle. ( 2.3 ) • Pancreatic Cancer: 1000 mg/m 2 over 30 minutes once weekly for the first 7 weeks, then one-week rest, then once weekly for 3 weeks of each 28-day cycle. ( 2.4 ) 2.1 Ovarian Cancer Recommended Dose and Schedule The recommended dosage of Gemcitabine Injection is 1000 mg/m 2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 administered intravenously on Day 1 after Gemcitabine Injection administration. Refer to carboplatin prescribing information for additional information. Dosage Modifications Recommended dosage modifications for Gemcitabine Injection for myelosuppression are described in Tables 1 and 2 [see Warnings and Precautions (5.2) ] . Refer to the recommended dosage modifications for non-…
Contraindications
4 CONTRAINDICATIONS Gemcitabine Injection is contraindicated in patients with a known hypersensitivity to gemcitabine. Reactions include anaphylaxis [see Adverse Reactions (6.1) ] . Patients with a known hypersensitivity to gemcitabine. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity [see Contraindications (4) ] • Schedule-Dependent Toxicity [see Warnings and Precautions (5.1) ] • Myelosuppression [see Warnings and Precautions (5.2) ] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.3) ] • Pulmonary Toxicity and Respiratory Failure [see Warnings and Precautions (5.4) ] • Hemolytic Uremic Syndrome [see Warnings and Precautions (5.5) ] • Hepatic Toxicity [see Warnings and Precautions (5.6) ] • Exacerbation of Radiation Therapy Toxicity [see Warnings and Precautions (5.8) ] • Capillary Leak Syndrome [see Warnings and Precautions (5.9) ] • Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.10) ] The most common adverse reactions for the single agent (≥20%) are nausea/vomiting, anemia, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), neutropenia, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea, and edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or …
Frequently Asked Questions
What is Gemcitabine used for?
Gemcitabine contains Gemcitabine. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Gemcitabine a controlled substance?
Gemcitabine is not classified as a controlled substance by the DEA.
What is the generic name for Gemcitabine?
The generic name for Gemcitabine is Gemcitabine. There are 8 other brand versions of Gemcitabine.
What is the NDC code for Gemcitabine 38 mg/mL?
The NDC (National Drug Code) for Gemcitabine 38 mg/mL is 0143-9341, listed by Hikma Pharmaceuticals USA Inc..