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Medicine

Diazepam 5 mg/mL oral solution

Diazepam · Oral
Available on requestPrescription onlyUS FDAControlled, schedule CIVGeneric name

Diazepam 5 mg/mL oral solution is a generic prescription medicine for oral 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

Store at 20° to 25°C (68° to 77°F). Diazepam Oral Solution (Concentrate), 5 mg…

Key facts

Active ingredient (INN)
Diazepam
Brand
Sold under the generic name
Strength
5 mg/mL
Dosage form
Oral solution
Route
Oral
Packs
30 mL
Manufacturer
Chartwell RX
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F). Diazepam Oral Solution (Concentrate), 5 mg per mL (Clear, yellow solution) is supplied as follows: NDC 62135-768-43: Bottle of 30 mL Store at 20° to 25°C (68° to 77°F). PROTECT FROM LIGHT.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Schedule CIV
ATC code
N05BA01 Diazepam
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
14 April 2014
Identifiers
RxCUI 309843, 309844DailyMed set ID cdb839fb-27e5-4a11-aed6-da0a7ab6e996NDC 62135-768Application ANDA204433

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
30 mL in 1 bottle62135-768-43Chartwell RX17 August 2022

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 November 1963Drugs@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 Diazepam

Clinical summary

Diazepam is a benzodiazepine indicated for the treatment of anxiety disorders Short-term treatment of anxiety symptoms Treatment of tremor, acute agitation, among other approved uses. MedsAcross supplies Diazepam 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 Diazepam

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

Data sources

Need Diazepam 5 mg/mL oral solution 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.