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MedsAcross

Medicine

Diphenhydramine 2500 mg/50 mL injection

Diphenhydramine · Intramuscular, intravenous
Available on requestPrescription onlyUS FDAGeneric name

Diphenhydramine 2500 mg/50 mL injection is a generic prescription medicine for intramuscular, intravenous use, 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

Storage as on the product label

Key facts

Active ingredient (INN)
Diphenhydramine
Brand
Sold under the generic name
Strength
2500 mg/50 mL
Dosage form
Injection
Route
Intramuscular, intravenous
Packs
1 vial of 50 mL
Manufacturer
A-S Medication Solutions
Origin register
US FDA, United States
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
D04AA32 Diphenhydramine
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
27 November 1972
Identifiers
RxCUI 1049633DailyMed set ID eedb421c-0020-4e5f-8b09-26a1cbabb681NDC 50090-0878Application ANDA080817

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

PackCodeLabelerMarketed since
1 vial in 1 carton / 50 mL in 1 vial50090-0878-0A-S Medication Solutions28 November 2014

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 4 March 1946Drugs@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 Diphenhydramine

Clinical summary

Diphenhydramine is a histamine-1 receptor antagonist. It is available as injection and oral solution for intramuscular and intravenous use. MedsAcross supplies Diphenhydramine 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 Diphenhydramine

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

Data sources

Need Diphenhydramine 2500 mg/50 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.