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MedsAcross

Medicine

Afrezza kit

Insulin human · Inhalation · Mannkind
Available on requestPrescription onlyUS FDA Cold chain

Afrezza kit is a prescription medicine containing Insulin human for inhalation use, marketed by Mannkind, 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. It ships in a temperature-controlled cold chain.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Cold chain

Storage 2ºC to 8ºC (36ºF to 46ºF) * If a foil package, blister card or strip…

Key facts

Active ingredient (INN)
Insulin human
Brand
Afrezza
Dosage form
Kit
Route
Inhalation
Packs
1 kit
Marketing authorisation holder
Mannkind
Manufacturer
Mannkind
Origin register
US FDA, United States
Storage
Storage 2ºC to 8ºC (36ºF to 46ºF) * If a foil package, blister card or strip is not refrigerated, the contents must be used within 10 days. Sealed (Unopened) Foil Package May be stored until the Expiration Date* Sealed (Unopened) Blister Cards and Strips Must be used within 1 month* In Use: Room Temperature Storage 25ºC (77ºF), excursions permitted 15ºC to 30ºC (59ºF to 86ºF) Sealed (Unopened)…
Cold chain
Yes, shipped temperature controlled
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
A10AB01 Insulin human
HS code (indicative)
3004.31Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
1 July 2016
Identifiers
RxCUI 1543202, 1543207, 1544488 +7DailyMed set ID 29f4637b-e204-425b-b89c-7238008d8c10NDC 47918-902, 47918-904, 47918-880 +1Application BLA022472

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
1 kit in 1 carton * 3 pouch in 1 package, combination / 2 blister pack in 1 pouch / 15 cartridge in 1 blister pack / 1 powder, metered in 1 cartridge * 3 pouch in 1 package, combination / 2 blister pack in 1 pouch / 15 cartridge in 1 blister pack / 1 powder, metered in 1 cartridge47918-880-18Mannkind1 July 2016
1 kit in 1 carton * 3 pouch in 1 package, combination / 2 blister pack in 1 pouch / 15 cartridge in 1 blister pack / 1 powder, metered in 1 cartridge * 3 pouch in 1 package, combination / 2 blister pack in 1 pouch / 15 cartridge in 1 blister pack / 1 powder, metered in 1 cartridge47918-898-18Mannkind4 December 2018
1 kit in 1 carton * 2 pouch in 1 package, combination / 2 blister pack in 1 pouch / 15 cartridge in 1 blister pack / 1 powder, metered in 1 cartridge * 2 pouch in 1 package, combination / 2 blister pack in 1 pouch / 15 cartridge in 1 blister pack / 1 powder, metered in 1 cartridge * 2 pouch in 1 package, combination / 2 blister pack in 1 pouch / 15 cartridge in 1 blister pack / 1 powder, metered in 1 cartridge47918-902-18Mannkind10 January 2017

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 28 October 1982Drugs@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 Insulin human

Clinical summary

Insulin human is an insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus requiring more than 200 units of insulin per day. MedsAcross supplies Insulin human 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 Insulin human

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

Data sources

Need Afrezza kit 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.