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Medicine

Olanzapine 10 mg/2 mL powder for injection

Olanzapine · Intramuscular
Available on requestPrescription onlyUS FDAGeneric name

Olanzapine 10 mg/2 mL powder for injection is a generic prescription medicine for intramuscular use, made by 9 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

The USP defines controlled room temperature as a temperature maintained…

Key facts

Active ingredient (INN)
Olanzapine
Brand
Sold under the generic name
Strength
10 mg/2 mL
Dosage form
Powder for injection
Route
Intramuscular
Packs
1 vial and 7 more
Manufacturers
Anthea PharmaIndiaCamber PharmaceuticalsIndiaGlenmark PharmaceuticalsIndiaSandozAmerican RegentHikma PharmaceuticalsNorthStar RxLLCQilu PharmaceuticalXGen Pharmaceuticals DJB
Origin register
US FDA, United States
Storage
The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F), that results in a mean kinetic temperature calculated to be not more than 25°C, and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
N05AH03 Olanzapine
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
24 October 2011
Identifiers
RxCUI 485968DailyMed set ID c1387008-6dc4-4f1e-ae29-fa7a0f0be684, 12ce860a-6f22-4db6-8acf-786b40f5a5a5, 2e709eaf-4116-4ee3-8dff-ace36181d115 +7NDC 31722-308, 67184-0573, 68462-952 +7Application ANDA217466, ANDA218116, ANDA220323 +3

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 vial in 1 carton / 2 mL in 1 vial83854-003-01Anthea PharmaIndia5 March 2026
1 vial in 1 carton / 2 mL in 1 vial31722-308-01Camber PharmaceuticalsIndia22 March 2023
1 vial in 1 carton / 2 mL in 1 vial68462-952-10Glenmark PharmaceuticalsIndia5 March 2026
1 vial in 1 carton / 2 mL in 1 vial0781-3159-72Sandoz24 October 2011
1 vial in 1 carton / 2 mL in 1 vial0781-9105-72Sandoz24 October 2011
1 vial, glass in 1 carton / 2 mL in 1 vial, glass0517-0955-01American Regent27 June 2012
1 vial in 1 carton / 2 mL in 1 vial0143-9199-01Hikma Pharmaceuticals18 September 2025
1 vial in 1 carton / 2 mL in 1 vial67184-0573-1Qilu Pharmaceutical11 November 2025
1 vial in 1 carton / 2 mL in 1 vial39822-1800-1XGen Pharmaceuticals DJB2 September 2025
1 vial in 1 carton / 2 mL in 1 vial72603-181-01NorthStar RxLLC16 October 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 30 September 1996Drugs@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

Alternatives

Other makers and brands of Olanzapine 10 mg/2 mL powder for injection.

Compare all 2

Other strengths and forms of Olanzapine

Clinical summary

Olanzapine is an atypical antipsychotic indicated for the treatment of schizophrenia, among other approved uses. It is available as tablets, orally disintegrating tablets and powder for injection for intramuscular and subcutaneous use. MedsAcross supplies Olanzapine 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 Olanzapine

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

Data sources

Need Olanzapine 10 mg/2 mL powder for 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.