Medicine
Atropine 8 mg/20 mL injection
Atropine 8 mg/20 mL injection is a generic prescription medicine for endotracheal, intramedullary, intramuscular, intravenous, subcutaneous 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
Store at 20°C to 25°C (68°F to 77°F). After initial use, store between 20°C to…
Key facts
- Active ingredient (INN)
- Atropine
- Brand
- Sold under the generic name
- Strength
- 8 mg/20 mL
- Dosage form
- Injection
- Route
- Endotracheal, intramedullary, intramuscular, intravenous, subcutaneous
- Packs
- 10 cartons of 20 mL, 10 vials of 20 mL, 1 vial of 20 mL and 9 more
- Manufacturers
- Accord HealthcareIndiaHealthFirstMedical Purchasing SolutionsRemedyrepackFresenius KabiHenry ScheinHikma PharmaceuticalsProPharma DistributionSomerset Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F). After initial use, store between 20°C to 25°C (68°F to 77°F) and discard within 24 hours Manufactured For: Accord Healthcare, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, USA.
- 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
- 23 January 2017
- Identifiers
- RxCUI 1190776DailyMed set ID f3cb74e9-b4ac-4efe-bd8e-8a71970ee7c7, 4c15d3cc-7888-4c82-b3f8-a5d93c5523df, 0aab13de-04bf-2a14-e063-6294a90aae11 +8NDC 16729-512, 0641-6251, 71872-7316 +8Application ANDA213424, ANDA213561, NDA209260 +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 |
|---|---|---|---|
| 10 carton in 1 box / 1 vial, multi-dose in 1 carton / 20 mL in 1 vial, multi-dose | 16729-512-43 | Accord HealthcareIndia | 25 March 2021 |
| 10 vial, multi-dose in 1 tray / 20 mL in 1 vial, multi-dose | 63323-580-20 | Fresenius Kabi | 23 January 2017 |
| 10 vial in 1 carton / 20 mL in 1 vial | 0641-6251-10 | Hikma Pharmaceuticals | 1 December 2021 |
| 10 vial in 1 carton / 20 mL in 1 vial | 70069-481-10 | Somerset Therapeutics | 9 December 2024 |
| 1 vial in 1 bag / 20 mL in 1 vial | 71872-7316-1 | Medical Purchasing Solutions | 19 October 2023 |
| 1 vial in 1 bag / 20 mL in 1 vial | 71872-7355-1 | Medical Purchasing Solutions | 24 July 2025 |
| 10 vial, multi-dose in 1 tray / 20 mL in 1 vial, multi-dose | 70518-4188-0 | Remedyrepack | 26 September 2024 |
| 10 vial in 1 carton / 20 mL in 1 vial | 70518-4329-0 | Remedyrepack | 15 April 2025 |
| 20 mL in 1 vial | 51662-1619-1 | HealthFirst | 10 November 2022 |
| 10 pouch in 1 case / 1 vial in 1 pouch / 20 mL in 1 vial | 51662-1619-3 | HealthFirst | 1 October 2022 |
| 1 vial, multi-dose in 1 bag / 20 mL in 1 vial, multi-dose | 0404-9804-20 | Henry Schein | 1 October 2024 |
| 20 mL in 1 vial, multi-dose | 84549-580-20 | ProPharma Distribution | 27 August 2025 |
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
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 AtropineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ATROPEN Auto-Injector prescribing information (Meridian Medical Technologies) · U.S. National Library of Medicine, DailyMed
- Ryjunea: European public assessment report (EPAR) · European Medicines Agency
Need Atropine 8 mg/20 mL injection for your hospital or patient?
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