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Medicine

Erythromycin 400 mg/5 mL oral suspension

Erythromycin · Oral
Available on requestPrescription onlyUS FDAGeneric name

Erythromycin 400 mg/5 mL oral suspension is a generic prescription medicine for oral use, made by 4 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 Erythromycin Ethylsuccinate for Oral Suspension USP, 200 mg/5 mL and 400…

Key facts

Active ingredient (INN)
Erythromycin
Brand
Sold under the generic name
Strength
400 mg/5 mL
Dosage form
Oral suspension
Route
Oral
Packs
100 mL and 2 more
Manufacturers
Amneal Pharmaceuticals NYANI PharmaceuticalsNivagen PharmaceuticalsWilshire Pharmaceuticals
Origin register
US FDA, United States
Storage
Store Erythromycin Ethylsuccinate for Oral Suspension USP, 200 mg/5 mL and 400 mg/5 mL, prior to mixing, below 86°F (30°C). After reconstitution, Erythromycin Ethylsuccinate for Oral Suspension USP, 200 mg/5 mL and 400 mg/5 mL must be stored at or below 77°F (25°C) and used within 35 days, refrigeration is not required.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
D10AF02 Erythromycin
HS code (indicative)
3004.20Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
25 March 2019
Identifiers
RxCUI 686400, 686418DailyMed set ID 3d80f96e-3bbe-4fa5-89a8-694c61dd5e8f, 596fa019-b0eb-4e57-93ff-195a765a2e91, 46f74c4f-10fc-44cf-aec4-d113f49149bc +2NDC 62559-631, 69238-1504, 75834-294 +2Application ANDA062055, ANDA211204, ANDA216212 +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 bottle60219-1504-2Amneal Pharmaceuticals NY2 December 2023
100 mL in 1 bottle69238-1504-2Amneal Pharmaceuticals NY4 November 2019
100 mL in 1 bottle62559-631-01ANI Pharmaceuticals25 March 2019
100 mL in 1 bottle75834-294-01Nivagen Pharmaceuticals1 February 2023
100 mL in 1 bottle52536-130-13Wilshire Pharmaceuticals25 March 2019

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 25 June 1964Drugs@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

Alternatives

Other makers and brands of Erythromycin 400 mg/5 mL oral suspension.

Compare 1

Other strengths and forms of Erythromycin

Clinical summary

Erythromycin is a macrolide antimicrobial indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below, among other approved uses. MedsAcross supplies Erythromycin 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 Erythromycin

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

Data sources

Need Erythromycin 400 mg/5 mL 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.