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MedsAcross

Medicine

Adalimumab kit

Available on requestPrescription onlyUS FDA Cold chainGeneric name

Adalimumab kit is a generic prescription medicine, 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. 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

Store in original carton until time of administration to protect from light.

Key facts

Active ingredient (INN)
Adalimumab
Brand
Sold under the generic name
Dosage form
Kit
Packs
2 trays, 2 kits, 1 kit and 33 more
Manufacturers
Biocon BiologicsIndiaCelltrionBoehringer Ingelheim PharmaceuticalsQuallent Pharmaceuticals HealthTeva Pharmaceuticals
Origin register
US FDA, United States
Storage
Store in original carton until time of administration to protect from light.
Cold chain
Yes, shipped temperature controlled
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
L04AB04 Adalimumab
HS code (indicative)
3002.15Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
1 October 2023
Identifiers
RxCUI 797544, 2640883, 2640891 +7DailyMed set ID 62f39a7c-00df-4519-a8d4-39bbd0a649ed, 2d19a877-1f5a-4731-800a-dddadc424080, f9986706-9c75-4335-a54f-09d7716dbcef +3NDC 0597-0565, 51759-360, 51759-361 +17Application BLA761058, BLA761299, BLA761219 +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
2 tray in 1 kit / 1 kit in 1 tray * 2 tray in 1 kit / 1 syringe in 1 tray / .4 mL in 1 syringe * 2 packet in 1 kit / 1 mL in 1 packet83257-020-42Biocon BiologicsIndia15 April 2024
2 tray in 1 kit / 1 kit in 1 tray * 2 tray in 1 kit / 1 syringe in 1 tray / .8 mL in 1 syringe * 2 packet in 1 kit / 1 mL in 1 packet83257-021-42Biocon BiologicsIndia15 April 2024
2 tray in 1 kit / 1 kit in 1 tray * 2 tray in 1 kit / 1 syringe in 1 tray / .8 mL in 1 syringe * 2 packet in 1 kit / 1 mL in 1 packet83257-022-32Biocon BiologicsIndia15 April 2024
2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .8 mL in 1 syringe * 2 packet in 1 tray / 1 mL in 1 packet0597-0545-22Boehringer Ingelheim Pharmaceuticals1 October 2023
2 kit in 1 carton / 1 kit in 1 kit * 2 packet in 1 tray / 1 mL in 1 packet * 1 syringe in 1 tray / .4 mL in 1 syringe0597-0555-80Boehringer Ingelheim Pharmaceuticals1 October 2023
2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .4 mL in 1 syringe * 2 packet in 1 tray / 1 mL in 1 packet0597-0565-20Boehringer Ingelheim Pharmaceuticals30 April 2024
2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .4 mL in 1 syringe * 2 packet in 1 tray / 1 mL in 1 packet0597-0575-50Boehringer Ingelheim Pharmaceuticals30 April 2024
2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .2 mL in 1 syringe * 2 packet in 1 tray / 1 mL in 1 packet0597-0585-89Boehringer Ingelheim Pharmaceuticals1 October 2023
2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .8 mL in 1 syringe * 2 packet in 1 tray / 1 mL in 1 packet0597-0595-20Boehringer Ingelheim Pharmaceuticals1 October 2023
2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .4 mL in 1 syringe * .4 mL in 1 pouch51759-310-59Teva Pharmaceuticals1 May 2026
1 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .8 mL in 1 syringe * .4 mL in 1 pouch51759-311-58Teva Pharmaceuticals1 May 2026
2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .4 mL in 1 syringe * .4 mL in 1 pouch51759-360-02Teva Pharmaceuticals1 July 2025
1 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .8 mL in 1 syringe * .4 mL in 1 pouch51759-361-17Teva Pharmaceuticals1 July 2025
1 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .4 mL in 1 syringe * 1 mL in 1 packet72606-022-01Celltrion30 November 2023
2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .4 mL in 1 syringe * 1 mL in 1 packet72606-022-02Celltrion30 November 2023
4 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .4 mL in 1 syringe * 1 mL in 1 packet72606-022-03Celltrion30 November 2023
6 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .4 mL in 1 syringe * 1 mL in 1 packet72606-022-04Celltrion30 November 2023
1 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .4 mL in 1 syringe * 1 mL in 1 packet72606-022-05Celltrion30 November 2023
2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .4 mL in 1 syringe * 1 mL in 1 packet72606-022-06Celltrion30 November 2023
4 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .4 mL in 1 syringe * 1 mL in 1 packet72606-022-07Celltrion30 November 2023
6 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .4 mL in 1 syringe * 1 mL in 1 packet72606-022-08Celltrion30 November 2023
1 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .4 mL in 1 syringe * 1 mL in 1 packet72606-022-09Celltrion30 November 2023
2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .4 mL in 1 syringe * 1 mL in 1 packet72606-022-10Celltrion30 November 2023
4 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .4 mL in 1 syringe * 1 mL in 1 packet72606-022-11Celltrion30 November 2023
6 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .4 mL in 1 syringe * 1 mL in 1 packet72606-022-12Celltrion30 November 2023
1 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .8 mL in 1 syringe * 1 mL in 1 packet72606-040-01Celltrion30 November 2023
1 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .8 mL in 1 syringe * 1 mL in 1 packet72606-040-02Celltrion30 November 2023
2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .8 mL in 1 syringe * 1 mL in 1 packet72606-040-03Celltrion30 November 2023
1 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .8 mL in 1 syringe * 1 mL in 1 packet72606-040-04Celltrion30 November 2023
2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .8 mL in 1 syringe * 1 mL in 1 packet72606-040-05Celltrion30 November 2023
3 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .8 mL in 1 syringe * 1 mL in 1 packet72606-040-06Celltrion30 November 2023
2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .2 mL in 1 syringe * 1 mL in 1 packet72606-041-01Celltrion30 November 2023
2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .4 mL in 1 syringe * 2 packet in 1 tray / 1 mL in 1 packet82009-144-22Quallent Pharmaceuticals Health30 April 2024
2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .4 mL in 1 syringe * 2 packet in 1 tray / 1 mL in 1 packet82009-146-22Quallent Pharmaceuticals Health30 April 2024
2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .8 mL in 1 syringe * 2 packet in 1 tray / 1 mL in 1 packet82009-148-22Quallent Pharmaceuticals Health30 April 2024
2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .8 mL in 1 syringe * 2 packet in 1 tray / 1 mL in 1 packet82009-150-22Quallent Pharmaceuticals Health30 April 2024
2 carton in 1 carton / 1 kit in 1 carton * .8 mL in 1 syringe, glass * 1 swab in 1 pouch65219-612-69—30 September 2024
3 carton in 1 carton / 1 kit in 1 carton * .8 mL in 1 syringe, glass * 1 swab in 1 pouch65219-612-89—30 September 2024
1 kit in 1 carton * .8 mL in 1 syringe, glass * 1 swab in 1 pouch65219-612-99—6 December 2023
1 kit in 1 carton * .8 mL in 1 syringe, glass * 1 swab in 1 pouch65219-620-20—30 June 2024
2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .4 mL in 1 syringe * .4 mL in 1 pouch82009-156-22—22 May 2024
2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .4 mL in 1 syringe * .4 mL in 1 pouch82009-158-22—31 July 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 31 December 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

Alternatives

Other makers and brands of Adalimumab kit.

Compare all 10

Other strengths and forms of Adalimumab

Clinical summary

Adalimumab is a tumor necrosis factor blocker indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. MedsAcross supplies Adalimumab 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 Adalimumab

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

Data sources

Need Adalimumab 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.