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Medicine

Atropine 10 mg/mL eye drops

Atropine · Ophthalmic
Available on requestPrescription onlyUS FDAGeneric name

Atropine 10 mg/mL eye drops is a generic prescription medicine for ophthalmic 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).

Key facts

Active ingredient (INN)
Atropine
Brand
Sold under the generic name
Strength
10 mg/mL
Dosage form
Eye drops
Route
Ophthalmic
Packs
1 bottle and 22 more
Manufacturers
Gland PharmaIndiaLifestar PharmaIndiaSomerset TherapeuticsAmneal Pharmaceuticals NYApotexEdenbridge PharmaceuticalsA-S Medication SolutionsNorthStar RxLLCRedpharm Drug
Origin register
US FDA, United States
Storage
Store at 20°C to 25°C (68°F to 77°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
26 November 2021
Identifiers
RxCUI 1190655DailyMed set ID b4736dbc-b7c8-4b33-b7a8-a47c5654a127, a116af5c-ba4c-408c-9a02-4bc33772aa8d, b5f78b2a-56d1-4400-9d2f-b033cc13d26e +9NDC 50090-7313, 68083-670, 68083-671 +17Application ANDA214752, ANDA219996, ANDA218148 +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.

PackCodeLabelerMarketed since
1 bottle, dropper in 1 carton / 2 mL in 1 bottle, dropper68083-669-01Gland PharmaIndia31 July 2026
1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper68083-670-01Gland PharmaIndia31 July 2026
1 bottle, dropper in 1 carton / 15 mL in 1 bottle, dropper68083-671-01Gland PharmaIndia31 July 2026
1 bottle in 1 carton / 2 mL in 1 bottle70756-651-25Lifestar PharmaIndia8 January 2024
1 bottle in 1 carton / 5 mL in 1 bottle70756-652-25Lifestar PharmaIndia8 January 2024
1 bottle in 1 carton / 15 mL in 1 bottle70756-653-35Lifestar PharmaIndia8 January 2024
1 bottle in 1 carton / 2 mL in 1 bottle70069-581-01Somerset Therapeutics4 July 2024
1 bottle in 1 carton / 5 mL in 1 bottle70069-582-01Somerset Therapeutics4 July 2024
1 bottle in 1 carton / 15 mL in 1 bottle70069-583-01Somerset Therapeutics12 February 2025
1 bottle in 1 carton / 5 mL in 1 bottle70069-716-01Somerset Therapeutics24 May 2024
1 bottle, dropper in 1 carton / 2 mL in 1 bottle, dropper60219-1748-2Amneal Pharmaceuticals NY19 July 2022
1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper60219-1749-3Amneal Pharmaceuticals NY19 July 2022
1 bottle, dropper in 1 carton / 15 mL in 1 bottle, dropper60219-1750-8Amneal Pharmaceuticals NY19 July 2022
1 bottle, dropper in 1 carton / 2 mL in 1 bottle, dropper60505-6226-0Apotex26 November 2021
1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper60505-6226-1Apotex26 November 2021
1 bottle, dropper in 1 carton / 15 mL in 1 bottle, dropper60505-6226-2Apotex7 February 2022
1 bottle in 1 carton / 2 mL in 1 bottle42799-826-01Edenbridge Pharmaceuticals6 May 2026
1 bottle in 1 carton / 5 mL in 1 bottle42799-826-02Edenbridge Pharmaceuticals6 May 2026
1 bottle in 1 carton / 15 mL in 1 bottle42799-826-03Edenbridge Pharmaceuticals6 May 2026
1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper50090-7000-0A-S Medication Solutions28 December 2023
1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper50090-7313-0A-S Medication Solutions14 October 2024
1 bottle in 1 carton / 5 mL in 1 bottle67296-2124-5Redpharm Drug8 January 2024
1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper67296-2200-5Redpharm Drug26 November 2021
1 bottle in 1 carton / 2 mL in 1 bottle72603-264-01NorthStar RxLLC1 September 2024
1 bottle in 1 carton / 5 mL in 1 bottle72603-264-02NorthStar RxLLC1 September 2024

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

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 10 mg/mL eye drops 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.