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Medicine

Docetaxel 80 mg/4 mL injection

Docetaxel · Intravenous
Available on requestPrescription onlyUS FDAGeneric name

Docetaxel 80 mg/4 mL injection is a generic prescription medicine for intravenous use, made by 12 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

Available on request

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
80 mg/4 mL
Dosage form
Injection
Route
Intravenous
Packs
4 mL, 1 vial of 4 mL and 11 more
Manufacturers
Dr. Reddy's LaboratoriesIndiaAccord HealthcareIndiaAvet PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaHospiraActavis PharmaAmneal PharmaceuticalsHikma PharmaceuticalsJiangsu Hengrui PharmaceuticalsMeitheal Pharmaceuticals
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). Retain in the original package to protect from 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
21 October 2010
Identifiers
RxCUI 1860480, 1860485, 1861411 +1DailyMed set ID 81686d37-a13f-46e2-b439-a84eb1433634, ff7fb2c2-97a7-4716-a269-925ca30cf0f1, dd0ca36d-1f54-4568-8d19-a7152addcd52 +11NDC 23155-904, 0143-9205, 0955-1021 +11Application ANDA216677, ANDA204490, NDA020449 +8

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.

PackCodeLabelerMarketed since
4 mL in 1 vial, glass43598-259-40Dr. Reddy's LaboratoriesIndia10 November 2014
4 mL in 1 vial, glass43598-610-40Dr. Reddy's LaboratoriesIndia22 August 2017
1 vial, multi-dose in 1 carton / 4 mL in 1 vial, multi-dose16729-267-64Accord HealthcareIndia2 August 2013
1 vial in 1 carton / 4 mL in 1 vial23155-904-31Avet PharmaceuticalsIndia15 December 2024
1 vial, glass in 1 carton / 4 mL in 1 vial, glass47335-895-40Sun Pharmaceutical IndustriesIndia26 November 2020
1 vial, multi-dose in 1 carton / 4 mL in 1 vial, multi-dose0409-0367-01Hospira24 August 2016
1 vial, multi-dose in 1 carton / 4 mL in 1 vial, multi-dose0409-5068-01Hospira28 June 2021
1 vial, glass in 1 carton / 4 mL in 1 vial, glass45963-765-52Actavis Pharma1 September 2014
1 vial, glass in 1 carton / 4 mL in 1 vial, glass70121-1222-1Amneal Pharmaceuticals19 January 2018
1 vial, glass in 1 carton / 4 mL in 1 vial, glass0143-9205-01Hikma Pharmaceuticals14 January 2021
1 vial, glass in 1 carton / 4 mL in 1 vial, glass57884-3042-1Jiangsu Hengrui Pharmaceuticals9 August 2017
1 vial, single-dose in 1 carton / 4 mL in 1 vial, single-dose71288-152-04Meitheal Pharmaceuticals13 May 2025
1 vial in 1 carton / 4 mL in 1 vial25021-245-04Sagent Pharmaceuticals15 September 2017
1 vial, glass in 1 carton / 4 mL in 1 vial, glass0955-1021-04Sanofi-Aventis21 October 2010

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 14 May 1996Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS 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 Docetaxel 80 mg/4 mL injection.

Compare 1

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 Docetaxel

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Docetaxel 80 mg/4 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.