Medicine
Testosterone 1.62% gel
Testosterone 1.62% gel is a generic prescription medicine for transdermal use, made by 9 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 controlled room temperature 20° to 25°C (68° to 77°F), excursions…
Key facts
- Active ingredient (INN)
- Testosterone
- Brand
- Sold under the generic name
- Strength
- 1.62%
- Dosage form
- Gel
- Route
- Transdermal
- Packs
- 1 bottle, 30 packets and 9 more
- Manufacturers
- Alembic PharmaceuticalsIndiaLupinIndiaActavis PharmaBryant Ranch PrepackEncube EthicalsPrasco LaboratoriesNorthStar RxXiromed9 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°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
- 10 April 2019
- Identifiers
- RxCUI 1597076, 1597126, 1597120DailyMed set ID 65981b8a-d5cc-1964-7eac-a07f032c2571, 6c7d2dec-6492-4d53-b110-61ffeae9ee61, 44a04f66-fd2a-45c7-934e-8f14c023ce14 +7NDC 72603-265, 63629-2352, 21922-030 +9Application ANDA210835, ANDA208620, ANDA209390 +4
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 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 62332-552-88 | Alembic PharmaceuticalsIndia | 4 March 2021 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 68180-941-11 | LupinIndia | 10 April 2019 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 0591-2924-18 | Actavis Pharma | 10 April 2019 |
| 30 packet in 1 carton / 2.5 g in 1 packet | 0591-2926-30 | Actavis Pharma | 12 February 2021 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 21922-030-20 | Encube Ethicals | 5 June 2024 |
| 30 packet in 1 carton / 2.5 g in 1 packet | 21922-030-52 | Encube Ethicals | 1 June 2026 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 70700-112-21 | Xiromed | 8 May 2020 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 63629-2352-1 | Bryant Ranch Prepack | 8 May 2020 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 72162-1962-2 | Bryant Ranch Prepack | 7 February 2024 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 66993-951-88 | Prasco Laboratories | 19 May 2025 |
| 30 packet in 1 carton / 2.5 g in 1 packet | 66993-952-30 | Prasco Laboratories | 1 December 2025 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 72603-265-01 | Northstar Rx | 24 January 2024 |
| 30 packet in 1 carton / 1.25 g in 1 packet | 45802-281-39 | — | 27 June 2019 |
| 30 packet in 1 carton / 2.5 g in 1 packet | 45802-366-65 | — | 6 June 2019 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 45802-754-01 | — | 12 October 2018 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 69238-1013-2 | — | 10 April 2019 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 63629-8455-1 | — | 12 October 2018 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 71335-2742-1 | — | 29 July 2025 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 72162-1426-2 | — | 5 December 2023 |
| 30 packet in 1 carton / 1.25 g in 1 packet | 16714-968-02 | — | 6 November 2019 |
| 30 packet in 1 carton / 2.5 g in 1 packet | 16714-969-02 | — | 6 November 2019 |
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 1.62% 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 1.62% 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.