Medicine
Docetaxel 160 mg/16 mL injection
Docetaxel 160 mg/16 mL injection is a generic prescription medicine for intravenous use, made by 9 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Freezing does not adversely affect the product. Store between 2°C and 25°C…
Key facts
- Active ingredient (INN)
- Docetaxel
- Brand
- Sold under the generic name
- Strength
- 160 mg/16 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 16 mL and 10 more
- Manufacturers
- Alembic PharmaceuticalsIndiaEugiaIndiaGland PharmaIndiaHospiraBaxter HealthcareMeitheal PharmaceuticalsMylan InstitutionalSagent PharmaceuticalsSandoz
- Origin register
- US FDA, United States
- Storage
- Freezing does not adversely affect the product. Store between 2°C and 25°C (36°F and 77°F). After initial puncture, Docetaxel Injection multiple-dose vials are stable for 28 days when stored between 2ºC to 8ºC and at room temperature, with or without protection from light. Retain in the original package to protect from bright light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01CD02 Docetaxel
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 March 2011
- Identifiers
- RxCUI 1093280, 1860619DailyMed set ID 0e0f06bd-d190-45da-be8b-062e8de01970, 9fb533da-a7ba-4c2b-8e4f-8e336ba55d12, 654319ae-e5f9-4a6a-b566-201923153b6e +10NDC 43066-010, 71288-144, 43066-048 +10Application NDA201525, ANDA209634, ANDA215744 +4
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, multi-dose in 1 carton / 16 mL in 1 vial, multi-dose | 46708-678-16 | Alembic PharmaceuticalsIndia | 28 February 2023 |
| 1 vial, multi-dose in 1 carton / 16 mL in 1 vial, multi-dose | 62332-678-16 | Alembic PharmaceuticalsIndia | 28 February 2023 |
| 1 vial, multi-dose in 1 carton / 16 mL in 1 vial, multi-dose | 55150-380-01 | EugiaIndia | 25 June 2021 |
| 1 vial, multi-dose in 1 carton / 16 mL in 1 vial, multi-dose | 68083-401-01 | Gland PharmaIndia | 1 July 2021 |
| 1 vial, multi-dose in 1 carton / 16 mL in 1 vial, multi-dose | 0409-0016-01 | Hospira | 10 January 2022 |
| 1 vial, multi-dose in 1 carton / 16 mL in 1 vial, multi-dose | 0409-0201-20 | Hospira | 17 March 2011 |
| 1 vial, multi-dose in 1 carton / 16 mL in 1 vial, multi-dose | 0409-1732-01 | Hospira | 28 June 2021 |
| 1 vial, multi-dose in 1 carton / 16 mL in 1 vial, multi-dose | 43066-010-01 | Baxter Healthcare | 19 February 2018 |
| 1 vial, multi-dose in 1 carton / 16 mL in 1 vial, multi-dose | 43066-048-16 | Baxter Healthcare | 27 November 2025 |
| 1 vial, multi-dose in 1 carton / 16 mL in 1 vial, multi-dose | 71288-144-16 | Meitheal Pharmaceuticals | 24 August 2018 |
| 1 vial, multi-dose in 1 carton / 16 mL in 1 vial, multi-dose | 67457-533-16 | Mylan Institutional | 5 September 2018 |
| 1 vial in 1 carton / 16 mL in 1 vial | 25021-254-16 | Sagent Pharmaceuticals | 1 August 2023 |
| 1 vial, multi-dose in 1 carton / 16 mL in 1 vial, multi-dose | 66758-050-03 | Sandoz | 29 June 2011 |
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.
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 Docetaxel 160 mg/16 mL injection.
Other strengths and forms of Docetaxel
Clinical summary
Docetaxel is a microtubule inhibitor indicated for breast Cancer (BC), among other approved uses. It is available as injection and kits for intravenous use. MedsAcross supplies Docetaxel 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 DocetaxelFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Docetaxel prescribing information (Sanofi-Aventis) · U.S. National Library of Medicine, DailyMed
- Taxotere: European public assessment report (EPAR) · European Medicines Agency
- Docetaxel Accord: European public assessment report (EPAR) · European Medicines Agency
Need Docetaxel 160 mg/16 mL injection for your hospital or patient?
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