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Medicine

Atropine 1 mg/10 mL injection

Atropine · Intravenous
Available on requestPrescription onlyUS FDAGeneric name

Atropine 1 mg/10 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and…

Key facts

Active ingredient (INN)
Atropine
Brand
Sold under the generic name
Strength
1 mg/10 mL
Dosage form
Injection
Route
Intravenous
Packs
10 mL, 10 syringes of 10 mL, 10 trays of 10 mL and 10 more
Manufacturers
Accord HealthcareIndiaAmneal PharmaceuticalsMedical Purchasing SolutionsProPharma DistributionHealthFirstHospiraInternational Medication SystemsMedefilRemedyrepack
Origin register
US FDA, United States
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
A03BA01 Atropine
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
19 January 2006
Identifiers
RxCUI 1190546, 1190551, 1190552DailyMed set ID 3d5c747f-3bf7-2597-e063-6394a90a828c, b72d0a82-6163-460f-965a-12f6da47370a, 3eeed115-0e17-c4b2-e063-6294a90a29b7 +8NDC 84549-340, 76329-3340, 84549-400 +8Application ANDA212461, ANDA214970, NDA021146 +2

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
10 mL in 1 syringe, glass16729-484-03Accord HealthcareIndia30 July 2021
10 syringe, glass in 1 carton / 10 mL in 1 syringe, glass16729-484-45Accord HealthcareIndia19 August 2021
10 tray in 1 carton / 5 syringe, glass in 1 tray / 10 mL in 1 syringe, glass70121-1706-2Amneal Pharmaceuticals9 January 2024
24 carton in 1 package / 1 syringe, glass in 1 carton / 10 mL in 1 syringe, glass70121-1706-4Amneal Pharmaceuticals18 September 2024
10 carton in 1 package / 1 syringe, plastic in 1 carton / 10 mL in 1 syringe, plastic0409-1630-10Hospira19 January 2006
10 carton in 1 package / 1 syringe in 1 carton / 10 mL in 1 syringe76329-3340-1International Medication Systems17 February 2021
10 syringe, plastic in 1 box / 10 mL in 1 syringe, plastic64253-400-91Medefil11 May 2023
1 carton in 1 bag / 1 syringe in 1 carton / 10 mL in 1 syringe71872-7252-1Medical Purchasing Solutions13 May 2021
1 syringe, glass in 1 bag / 10 mL in 1 syringe, glass71872-7298-1Medical Purchasing Solutions8 August 2022
10 mL in 1 syringe84549-340-01ProPharma Distribution1 September 2025
10 mL in 1 syringe, plastic84549-400-91ProPharma Distribution16 September 2025
10 pouch in 1 case / 1 carton in 1 pouch / 1 syringe in 1 carton / 10 mL in 1 syringe51662-1527-3HealthFirst22 September 2023
10 carton in 1 package / 1 syringe in 1 carton / 10 mL in 1 syringe70518-3120-0Remedyrepack14 June 2021
1 syringe, plastic in 1 carton / 10 mL in 1 syringe, plastic51662-1289-1—23 September 2018
10 pouch in 1 case / 1 carton in 1 pouch / 1 syringe, plastic in 1 carton / 10 mL in 1 syringe, plastic51662-1289-3—12 December 2022
10 carton in 1 bag / 1 syringe, plastic in 1 carton / 10 mL in 1 syringe, plastic71872-7002-1—28 February 2018

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 15 May 1973Drugs@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 Atropine 1 mg/10 mL injection.

Compare 1

Other strengths and forms of Atropine

Clinical summary

Atropine is an anticholinergic indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients. MedsAcross supplies Atropine 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 Atropine

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

Data sources

Need Atropine 1 mg/10 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.