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Medicine

Nilotinib 150 mg capsule

Nilotinib · Oral
Available on requestPrescription onlyUS FDAGeneric name

Nilotinib 150 mg capsule is a generic prescription medicine for oral use, made by 7 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

Nilotinib 50 mg capsules are supplied in bottles and nilotinib 150 mg and 200…

Key facts

Active ingredient (INN)
Nilotinib
Brand
Sold under the generic name
Strength
150 mg
Dosage form
Capsule
Route
Oral
Packs
4 blister pack, 4 cartons, 8 blister pack and 8 more
Manufacturers
CiplaIndiaNovadoz PharmaceuticalsIndiaTorrent PharmaceuticalsIndiaCamber PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaAvKAREApotex
Origin register
US FDA, United States
Storage
Nilotinib 50 mg capsules are supplied in bottles and nilotinib 150 mg and 200 mg capsules are supplied in blister packs. 150 mg Carton of 4 blister packs of (4x28).......................NDC 73190-033-12 Blisters of 28 capsules................................NDC 73190-033-11 200 mg Carton of 4 blister packs of (4x28).......................NDC 73190-034-12 Blisters of 28…
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
L01EA03 Nilotinib
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
23 May 2025
Identifiers
RxCUI 746606, 997653, 2715459 +3DailyMed set ID 4c0bc799-ce6a-822a-e063-6394a90ab748, 86dc5507-ae0a-43d2-8d5e-5b0568ce9c5e, e27c3e09-bc4f-4f01-be05-1c43ac72285d +4NDC 73190-033, 31722-779, 69097-031 +4Application ANDA218544, ANDA209651, NDA218922 +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
4 blister pack in 1 carton / 28 capsule in 1 blister pack31722-779-33Camber PharmaceuticalsIndia19 November 2025
4 carton in 1 carton / 4 blister pack in 1 carton / 7 capsule in 1 blister pack69097-031-74CiplaIndia18 June 2025
4 carton in 1 carton / 2 blister pack in 1 carton / 14 capsule in 1 blister pack69097-031-91CiplaIndia18 June 2025
8 blister pack in 1 carton / 14 capsule in 1 blister pack43598-455-46Dr. Reddy's LaboratoriesIndia19 November 2025
28 capsule in 1 blister pack72205-238-63Novadoz PharmaceuticalsIndia20 November 2025
4 blister pack in 1 carton / 28 capsule in 1 blister pack72205-238-64Novadoz PharmaceuticalsIndia20 November 2025
4 blister pack in 1 carton / 28 capsule in 1 blister pack13668-710-57Torrent PharmaceuticalsIndia16 December 2025
1 blister pack in 1 carton / 28 capsule in 1 blister pack13668-710-91Torrent PharmaceuticalsIndia16 December 2025
4 carton in 1 carton / 2 blister pack in 1 carton / 14 capsule in 1 blister pack60505-3801-2Apotex23 May 2025
28 capsule in 1 blister pack73190-033-11AvKARE2 March 2026
4 blister pack in 1 carton / 28 capsule in 1 blister pack73190-033-12AvKARE2 March 2026

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 29 October 2007Drugs@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 Nilotinib 150 mg capsule.

Compare 1

Other strengths and forms of Nilotinib

Clinical summary

Nilotinib is a kinase inhibitor indicated for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. MedsAcross supplies Nilotinib 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 Nilotinib

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

Data sources

Need Nilotinib 150 mg capsule 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.