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Medicine

Amoxicillin 200 mg/5 mL powder for oral suspension

Amoxicillin · Oral
Available on requestPrescription onlyUS FDAGeneric name

Amoxicillin 200 mg/5 mL powder for oral suspension is a generic prescription medicine for oral 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 dry powder at 20° to 25°C (68° to 77°F), excursions permitted to 15° to…

Key facts

Active ingredient (INN)
Amoxicillin
Brand
Sold under the generic name
Strength
200 mg/5 mL
Dosage form
Powder for oral suspension
Route
Oral
Packs
100 mL, 50 mL, 75 mL and 23 more
Manufacturers
Aurobindo PharmaIndiaPreferred PharmaceuticalsChartwell RXHawaii RepackHikma PharmaceuticalsRising Pharma HoldingsSandozTeva PharmaceuticalsProficient Rx
Origin register
US FDA, United States
Storage
Store dry powder at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
J01CA04 Amoxicillin
HS code (indicative)
3004.10Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
2 April 2003
Identifiers
RxCUI 308189, 313850, 239191 +7DailyMed set ID 573fcf4a-2b87-45d9-ac73-e1dec4fbc28b, c84082fc-ea07-4e73-99c5-8356b957a1c5, 13bd4214-9b7f-425b-af5f-fc1ddc678230 +9NDC 68788-8324, 68788-8611, 0781-6156 +9Application ANDA065334, ANDA065119, ANDA065378 +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.

PackCodeLabelerMarketed since
100 mL in 1 bottle65862-070-01Aurobindo PharmaIndia28 December 2006
50 mL in 1 bottle65862-070-50Aurobindo PharmaIndia28 December 2006
75 mL in 1 bottle65862-070-75Aurobindo PharmaIndia28 December 2006
100 mL in 1 bottle62135-088-01Chartwell RX16 July 2026
50 mL in 1 bottle62135-088-50Chartwell RX16 July 2026
75 mL in 1 bottle62135-088-75Chartwell RX16 July 2026
100 mL in 1 bottle0143-9886-01Hikma Pharmaceuticals19 June 2006
50 mL in 1 bottle0143-9886-50Hikma Pharmaceuticals19 June 2006
75 mL in 1 bottle0143-9886-75Hikma Pharmaceuticals19 June 2006
100 mL in 1 bottle57237-032-01Rising Pharma Holdings28 December 2006
50 mL in 1 bottle57237-032-50Rising Pharma Holdings28 December 2006
75 mL in 1 bottle57237-032-75Rising Pharma Holdings28 December 2006
100 mL in 1 bottle0781-6156-46Sandoz26 March 2007
50 mL in 1 bottle0781-6156-52Sandoz26 March 2007
75 mL in 1 bottle0781-6156-57Sandoz26 March 2007
100 mL in 1 bottle0093-4160-73Teva Pharmaceuticals2 April 2003
50 mL in 1 bottle0093-4160-76Teva Pharmaceuticals1 July 2003
75 mL in 1 bottle0093-4160-78Teva Pharmaceuticals1 July 2003
100 mL in 1 bottle68788-7323-1Preferred Pharmaceuticals12 March 2019
100 mL in 1 bottle68788-8324-1Preferred Pharmaceuticals19 January 2023
100 mL in 1 bottle68788-8611-1Preferred Pharmaceuticals20 March 2024
100 mL in 1 bottle68788-8852-1Preferred Pharmaceuticals24 March 2025
50 mL in 1 bottle85534-0071-0Hawaii Repack3 July 2026
75 mL in 1 bottle85534-0071-1Hawaii Repack3 July 2026
100 mL in 1 bottle85534-0071-2Hawaii Repack3 July 2026
100 mL in 1 bottle71205-775-00Proficient Rx15 March 2023

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 18 January 1974Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
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 Amoxicillin

Clinical summary

Amoxicillin is a penicillin-class antibacterial indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species, among other approved uses. It is available as capsules, powder for oral suspension and tablets. MedsAcross supplies Amoxicillin 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 Amoxicillin

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

Data sources

Need Amoxicillin 200 mg/5 mL powder for oral suspension 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.