Medicine
Testosterone 1% gel
Testosterone 1% gel is a generic prescription medicine for topical use, made by 2 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Testosterone
- Brand
- Sold under the generic name
- Strength
- 1%
- Dosage form
- Gel
- Route
- Topical
- Packs
- 2 bottles, 30 packets, 30 tubes and 2 more
- Manufacturers
- Actavis PharmaUpsher-Smith Laboratories
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIII
- ATC code
- G03BA03 Testosterone
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 June 2014
- Identifiers
- RxCUI 1596780, 1597123, 1597129DailyMed set ID 5834d34f-839d-412c-b74c-da1dad2cfa88, a887020f-b41f-49fe-8379-f01147b2a796NDC 0591-3216, 0591-3217, 0591-2921 +1Application ANDA076737, NDA204399
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 |
|---|---|---|---|
| 2 bottle, pump in 1 carton / 75 g in 1 bottle, pump | 0591-2921-02 | Actavis Pharma | 14 December 2015 |
| 30 packet in 1 carton / 2.5 g in 1 packet | 0591-3216-30 | Actavis Pharma | 4 December 2015 |
| 30 packet in 1 carton / 5 g in 1 packet | 0591-3217-30 | Actavis Pharma | 4 December 2015 |
| 30 tube in 1 carton / 5 g in 1 tube | 0832-1120-05 | Upsher-Smith Laboratories | 16 June 2014 |
| 30 packet in 1 carton / 5 g in 1 packet | 0832-1120-35 | Upsher-Smith Laboratories | 16 June 2014 |
| 30 dose pack in 1 carton / 2.5 g in 1 dose pack | 64380-151-02 | — | 27 June 2022 |
| 30 dose pack in 1 carton / 5 g in 1 dose pack | 64380-152-02 | — | 27 June 2022 |
| 30 tube in 1 carton / 5 g in 1 tube | 0591-3524-30 | — | 12 October 2017 |
| 30 packet in 1 carton / 5 g in 1 packet | 21922-019-02 | — | 10 January 2021 |
| 2 container in 1 carton / 75 g in 1 container | 21922-019-47 | — | 14 February 2024 |
| 30 packet in 1 carton / 25 g in 1 packet | 21922-019-52 | — | 12 August 2024 |
| 2 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 66993-953-44 | — | 19 May 2025 |
| 30 packet in 1 carton / 2.5 g in 1 packet | 66993-954-30 | — | 1 December 2025 |
| 30 packet in 1 carton / 5 g in 1 packet | 66993-955-30 | — | 1 December 2025 |
| 30 packet in 1 carton / 5 g in 1 packet | 72162-1274-3 | — | 13 February 2025 |
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 Testosterone 1% gel.
Other strengths and forms of Testosterone
Clinical summary
Testosterone is an androgen indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. It is available as gel, topical solution and implant pellets for transdermal and nasal use. MedsAcross supplies Testosterone 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 TestosteroneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Testosterone prescribing information (Prasco Laboratories) · U.S. National Library of Medicine, DailyMed
Need Testosterone 1% gel 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.