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MedsAcross

Medicine

Aripiprazole 1 mg/mL oral solution

Aripiprazole · Oral
Available on requestPrescription onlyUS FDAGeneric name

Aripiprazole 1 mg/mL oral solution is a generic prescription medicine for oral use, made by 11 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 at 20° to 25°C (68° to 77°F).

Key facts

Active ingredient (INN)
Aripiprazole
Brand
Sold under the generic name
Strength
1 mg/mL
Dosage form
Oral solution
Route
Oral
Packs
1 bottle, 150 mL, 237 mL and 10 more
Manufacturers
Aurobindo PharmaIndiaCamber PharmaceuticalsIndiaAtlantic BiologicalsLannettAdvagen PharmaAmneal PharmaceuticalsApotexChartwell RXNorthStar RxLLCQuagen Pharmaceuticals
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
N05AX12 Aripiprazole
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
17 August 2015
Identifiers
RxCUI 485496DailyMed set ID fcabd777-dcb7-452c-821c-575a5991c90a, 4a0a2f6c-d7bb-48d1-b5ca-066f27f78e41, 1d27462e-45c7-4335-9092-84c340e06a2c +8NDC 59651-110, 72603-445, 62135-904 +8Application ANDA210479, ANDA216150, ANDA215595 +6

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
1 bottle in 1 carton / 150 mL in 1 bottle59651-110-55Aurobindo PharmaIndia29 January 2019
1 bottle in 1 carton / 150 mL in 1 bottle31722-684-15Camber PharmaceuticalsIndia1 November 2023
1 bottle in 1 carton / 150 mL in 1 bottle72888-100-20Advagen Pharma27 October 2022
1 bottle in 1 carton / 150 mL in 1 bottle65162-893-74Amneal Pharmaceuticals17 August 2015
1 bottle in 1 carton / 150 mL in 1 bottle60505-0404-5Apotex8 October 2015
150 mL in 1 bottle62135-904-51Chartwell RX28 April 2025
150 mL in 1 bottle, plastic54838-570-59Lannett17 August 2015
237 mL in 1 bottle, plastic54838-570-70Lannett17 August 2015
1 bottle in 1 carton / 150 mL in 1 bottle70752-114-07Quagen Pharmaceuticals15 December 2025
1 bottle in 1 carton / 150 mL in 1 bottle66689-735-05VistaPharm19 June 2020
72 cup, unit-dose in 1 box, unit-dose / 5 mL in 1 cup, unit-dose17856-0684-1Atlantic Biologicals29 January 2025
72 cup, unit-dose in 1 box, unit-dose / 10 mL in 1 cup, unit-dose17856-0684-2Atlantic Biologicals29 January 2025
1 bottle in 1 carton / 150 mL in 1 bottle72603-445-01NorthStar RxLLC1 May 2024

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 2002Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
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 Aripiprazole

Clinical summary

Aripiprazole is an atypical antipsychotic. It is available as tablets, orally disintegrating tablets and oral solution for intramuscular use. MedsAcross supplies Aripiprazole 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 Aripiprazole

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

Data sources

Need Aripiprazole 1 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.