Medicine
Gemcitabine 1998.8 mg/52.6 mL injection
Gemcitabine 1998.8 mg/52.6 mL injection is a generic prescription medicine for intravenous use, made by 4 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store at 2° to 8°C (36° to 46°F). Do not freeze.
Key facts
- Active ingredient (INN)
- Gemcitabine
- Brand
- Sold under the generic name
- Strength
- 1998.8 mg/52.6 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 52.6 mL and 3 more
- Manufacturers
- HospiraMeitheal PharmaceuticalsHikma PharmaceuticalsSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 2° to 8°C (36° to 46°F). Do not freeze.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01BC05 Gemcitabine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 22 August 2011
- Identifiers
- RxCUI 1720960, 1720975, 1720977DailyMed set ID d80176fe-3e8b-48be-87c2-9c603013b3fa, e18ed1cb-7dd0-4001-bfda-17d1f4587fb8, dc02a23b-3ff9-4441-aa91-8e9e629a7315 +3NDC 0143-9342, 0409-0182, 71288-117 +1Application ANDA213175, NDA200795, ANDA212129 +1
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, single-dose in 1 carton / 52.6 mL in 1 vial, single-dose | 0409-0182-01 | Hospira | 22 August 2011 |
| 1 vial, single-dose in 1 carton / 52.6 mL in 1 vial, single-dose | 0409-0182-25 | Hospira | 29 July 2013 |
| 1 vial, single-dose in 1 carton / 52.6 mL in 1 vial, single-dose | 71288-117-54 | Meitheal Pharmaceuticals | 11 December 2020 |
| 1 vial, single-dose in 1 carton / 52.6 mL in 1 vial, single-dose | 71288-117-93 | Meitheal Pharmaceuticals | 11 December 2020 |
| 1 vial in 1 carton / 52.6 mL in 1 vial | 0143-9342-01 | Hikma Pharmaceuticals | 17 October 2025 |
| 1 vial in 1 carton / 52.6 mL in 1 vial | 25021-239-52 | Sagent Pharmaceuticals | 15 January 2019 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 15 May 1996 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Gemcitabine 1998.8 mg/52.6 mL injection.
Other strengths and forms of Gemcitabine
Clinical summary
Gemcitabine 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, among other approved uses. MedsAcross supplies Gemcitabine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about GemcitabineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Gemcitabine prescribing information (Hospira) · U.S. National Library of Medicine, DailyMed
Need Gemcitabine 1998.8 mg/52.6 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.