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Medicine

Aripiprazole 15 mg orally disintegrating tablet

Aripiprazole · Oral
Available on requestPrescription onlyUS FDAGeneric name

Aripiprazole 15 mg orally disintegrating tablet is a generic prescription medicine for oral use, made by 5 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), excursions permitted to 15-30°C (59-86°F).

Key facts

Active ingredient (INN)
Aripiprazole
Brand
Sold under the generic name
Strength
15 mg
Dosage form
Orally disintegrating tablet
Route
Oral
Packs
30 tablets, 3 blister pack, 60 tablets and 9 more
Manufacturers
Alembic PharmaceuticalsIndiaAurobindo PharmaIndiaViona PharmaceuticalsIndiaSquare PharmaceuticalsBionpharma
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F), excursions permitted to 15-30°C (59-86°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
21 May 2015
Identifiers
RxCUI 643019, 643022, 643027 +1DailyMed set ID de2dc5fd-ecb4-4445-9cfb-10e64fe3269d, 476b92f3-cf7b-4c09-ac67-6ed35e6811d5, 720bc395-777d-4e5d-9571-aad5827dbf6d +3NDC 62332-104, 59651-515, 69452-339 +3Application ANDA202102, ANDA216208, ANDA202547 +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
30 tablet, orally disintegrating in 1 carton46708-261-10Alembic PharmaceuticalsIndia21 May 2015
30 tablet, orally disintegrating in 1 carton62332-104-30Alembic PharmaceuticalsIndia7 July 2016
3 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack59651-515-03Aurobindo PharmaIndia18 February 2026
30 tablet, orally disintegrating in 1 bottle59651-515-30Aurobindo PharmaIndia18 February 2026
30 tablet, orally disintegrating in 1 bottle72578-107-06Viona PharmaceuticalsIndia20 July 2022
3 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack72578-107-78Viona PharmaceuticalsIndia22 February 2023
30 tablet, orally disintegrating in 1 bottle, plastic69452-339-13Bionpharma7 February 2022
30 tablet, orally disintegrating in 1 bottle76483-101-00Square Pharmaceuticals20 July 2022
60 tablet, orally disintegrating in 1 bottle76483-101-01Square Pharmaceuticals20 July 2022
90 tablet, orally disintegrating in 1 bottle76483-101-02Square Pharmaceuticals20 July 2022
120 tablet, orally disintegrating in 1 bottle76483-101-03Square Pharmaceuticals20 July 2022
30 tablet, orally disintegrating in 1 carton76483-101-04Square Pharmaceuticals22 February 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 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 15 mg orally disintegrating tablet 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.