Medicine
Ustekinumab 45 mg/0.5 mL injection
Ustekinumab 45 mg/0.5 mL injection is a generic prescription medicine for subcutaneous use, made by 4 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store Ustekinumab-aekn vials and prefilled syringes refrigerated between 36°F…
Key facts
- Active ingredient (INN)
- Ustekinumab
- Brand
- Sold under the generic name
- Strength
- 45 mg/0.5 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 tray of 0.5 mL, 1 syringe of 0.5 mL, 1 vial of 0.5 mL and 4 more
- Manufacturers
- Janssen BiotechQuallent Pharmaceuticals HealthTeva PharmaceuticalsFresenius Kabi
- Origin register
- US FDA, United States
- Storage
- Store Ustekinumab-aekn vials and prefilled syringes refrigerated between 36°F to 46°F (2°C to 8°C). Do not freeze. If needed, individual prefilled syringes may be stored at room temperature up to 86°F (30°C) for a maximum single period of up to 30 days in the original carton to protect from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AC05 Ustekinumab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 April 2025
- Identifiers
- RxCUI 2705393, 2705400, 2705557 +7DailyMed set ID 052a3fb2-21c3-4c4e-a01e-afdd1accd1cd, 2b34392a-ecf6-41bd-8706-d4e9f0b25da8, 183a1dff-ef33-4ddb-ba38-f7861b0f77ad +2NDC 51759-413, 82009-160, 82009-161 +3Application BLA761343, BLA761373, BLA125261 +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.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 tray in 1 carton / 1 syringe, glass in 1 tray / .5 mL in 1 syringe, glass | 51759-413-32 | Teva Pharmaceuticals | 23 December 2025 |
| 1 tray in 1 carton / 1 syringe, glass in 1 tray / .5 mL in 1 syringe, glass | 51759-709-32 | Teva Pharmaceuticals | 2 June 2025 |
| 1 syringe in 1 carton / .5 mL in 1 syringe | 65219-862-01 | Fresenius Kabi | 15 November 2025 |
| 1 syringe in 1 carton / .5 mL in 1 syringe | 57894-440-01 | Janssen Biotech | 1 April 2025 |
| 1 vial, single-use in 1 carton / .5 mL in 1 vial, single-use | 57894-440-03 | Janssen Biotech | 1 April 2025 |
| 1 syringe in 1 carton / .5 mL in 1 syringe | 82009-160-11 | Quallent Pharmaceuticals Health | 15 April 2025 |
| .5 mL in 1 vial | 82009-161-94 | Quallent Pharmaceuticals Health | 15 February 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.
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 Ustekinumab 45 mg/0.5 mL injection.
- Pyzchiva 45 mg/0.5 mL injectionAvailable on requestCordavisUS FDA4 packs Cold chain
- Wezlana 45 mg/0.5 mL injectionAvailable on requestNuvailaUS FDA4 packs Cold chain
- Otulfi 45 mg/0.5 mL injectionAvailable on requestFresenius KabiUS FDA2 packs Cold chain
- Selarsdi 45 mg/0.5 mL injectionAvailable on requestTeva PharmaceuticalsUS FDA2 packs Cold chain
- Starjemza 45 mg/0.5 mL injectionAvailable on requestHikma PharmaceuticalsUS FDA2 packs Cold chain
- Stelara 45 mg/0.5 mL injectionAvailable on requestJanssen BiotechUS FDA2 packs Cold chain
Other strengths and forms of Ustekinumab
Clinical summary
Ustekinumab is an interleukin-12 antagonist indicated for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. MedsAcross supplies Ustekinumab 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 UstekinumabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ustekinumab prescribing information (Janssen Biotech) · U.S. National Library of Medicine, DailyMed
- Stelara: European public assessment report (EPAR) · European Medicines Agency
- Fymskina: European public assessment report (EPAR) · European Medicines Agency
Need Ustekinumab 45 mg/0.5 mL 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.