Medicine
Testosterone 1.62% gel
Testosterone 1.62% gel is a generic prescription medicine for topical 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.
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°-25°C (68°-77°F), excursions permitted…
Key facts
- Active ingredient (INN)
- Testosterone
- Brand
- Sold under the generic name
- Strength
- 1.62%
- Dosage form
- Gel
- Route
- Topical
- Packs
- 30 packets, 1 bottle and 6 more
- Manufacturers
- Bryant Ranch PrepackPadagis Israel PharmaceuticalsNorthStar RxAmneal Pharmaceuticals NY
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature 20°-25°C (68°-77°F), excursions permitted to 15°- 30°C (59°- 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
- 12 October 2018
- Identifiers
- RxCUI 1597076, 1597120, 1597126DailyMed set ID 9e10a37a-9c40-456b-a362-2fa8eae31e84, 2d55b825-8eab-4091-bdf2-9c52d111b8eb, 54fcdcb9-fb0e-4164-9e51-f2a5feae3217 +3NDC 71335-2742, 16714-969, 45802-754 +6Application ANDA204268, ANDA205781, ANDA207373
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 |
|---|---|---|---|
| 30 packet in 1 carton / 1.25 g in 1 packet | 45802-281-39 | Padagis Israel Pharmaceuticals | 27 June 2019 |
| 30 packet in 1 carton / 2.5 g in 1 packet | 45802-366-65 | Padagis Israel Pharmaceuticals | 6 June 2019 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 45802-754-01 | Padagis Israel Pharmaceuticals | 12 October 2018 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 69238-1013-2 | Amneal Pharmaceuticals NY | 10 April 2019 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 63629-8455-1 | Bryant Ranch Prepack | 12 October 2018 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 71335-2742-1 | Bryant Ranch Prepack | 29 July 2025 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 72162-1426-2 | Bryant Ranch Prepack | 5 December 2023 |
| 30 packet in 1 carton / 1.25 g in 1 packet | 16714-968-02 | Northstar Rx | 6 November 2019 |
| 30 packet in 1 carton / 2.5 g in 1 packet | 16714-969-02 | Northstar Rx | 6 November 2019 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 62332-552-88 | — | 4 March 2021 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 68180-941-11 | — | 10 April 2019 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 0591-2924-18 | — | 10 April 2019 |
| 30 packet in 1 carton / 2.5 g in 1 packet | 0591-2926-30 | — | 12 February 2021 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 21922-030-20 | — | 5 June 2024 |
| 30 packet in 1 carton / 2.5 g in 1 packet | 21922-030-52 | — | 1 June 2026 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 70700-112-21 | — | 8 May 2020 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 63629-2352-1 | — | 8 May 2020 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 72162-1962-2 | — | 7 February 2024 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 66993-951-88 | — | 19 May 2025 |
| 30 packet in 1 carton / 2.5 g in 1 packet | 66993-952-30 | — | 1 December 2025 |
| 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump | 72603-265-01 | — | 24 January 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.
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.