Medicine
Ammonium lactate 12% cream
Ammonium lactate 12% cream is a generic prescription medicine for topical use, made by 6 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)
- Ammonium lactate
- Brand
- Sold under the generic name
- Strength
- 12%
- Dosage form
- Cream
- Route
- Topical
- Packs
- 385 g, 1 tube, 2 tubes and 10 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaViona PharmaceuticalsIndiaZydus LifesciencesIndiaBryant Ranch PrepackPadagis Israel PharmaceuticalsRemedyrepack
- 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
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 April 2003
- Identifiers
- RxCUI 543460DailyMed set ID 9745b6ce-f532-4e80-b6e9-477ab9db4e30, 170f8764-a180-49fa-b406-44f5b7921a66, 10a894e6-d23a-4142-8c9f-7bf96be9b991 +5NDC 51672-1301, 63629-8608, 70771-1988 +5Application ANDA075883, ANDA075774, ANDA217815
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 |
|---|---|---|---|
| 385 g in 1 bottle, plastic | 51672-1301-0 | Sun Pharmaceutical IndustriesIndia | 10 April 2003 |
| 1 tube in 1 carton / 140 g in 1 tube | 51672-1301-2 | Sun Pharmaceutical IndustriesIndia | 1 July 2024 |
| 2 tube in 1 carton / 140 g in 1 tube | 51672-1301-4 | Sun Pharmaceutical IndustriesIndia | 10 April 2003 |
| 2 tube in 1 carton / 140 g in 1 tube | 72578-203-10 | Viona PharmaceuticalsIndia | 2 October 2026 |
| 385 g in 1 bottle | 72578-203-11 | Viona PharmaceuticalsIndia | 2 October 2026 |
| 2 tube in 1 carton / 140 g in 1 tube | 70771-1988-6 | Zydus LifesciencesIndia | 2 October 2026 |
| 385 g in 1 bottle | 70771-1988-7 | Zydus LifesciencesIndia | 2 October 2026 |
| 385 g in 1 bottle, pump | 45802-493-26 | Padagis Israel Pharmaceuticals | 19 February 2007 |
| 385 g in 1 bottle | 45802-493-38 | Padagis Israel Pharmaceuticals | 16 March 2026 |
| 2 tube in 1 carton / 140 g in 1 tube | 63629-8608-1 | Bryant Ranch Prepack | 9 July 2021 |
| 385 g in 1 bottle, pump | 63629-8609-1 | Bryant Ranch Prepack | 19 February 2007 |
| 2 tube in 1 carton / 140 g in 1 tube | 72162-1413-2 | Bryant Ranch Prepack | 16 August 2023 |
| 2 tube in 1 carton / 140 g in 1 tube | 70518-3619-0 | Remedyrepack | 20 January 2023 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 24 April 1985 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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
Other strengths and forms of Ammonium lactate
Clinical summary
Ammonium lactate is an alpha-hydroxy acid indicated for the treatment of ichthyosis vulgaris and xerosis. It is available as cream and lotion for topical use. MedsAcross supplies Ammonium lactate 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 Ammonium lactateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Ammonium lactate prescribing information (Viona Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Ammonium lactate 12% cream 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.