Medicine
Pimecrolimus 1% cream
Pimecrolimus 1% cream 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
Do not freeze. Store at 25°C (77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Pimecrolimus
- Brand
- Sold under the generic name
- Strength
- 1%
- Dosage form
- Cream
- Route
- Topical
- Packs
- 1 tube, 30 g, 60 g and 7 more
- Manufacturers
- Glenmark PharmaceuticalsIndiaActavis PharmaOceanside PharmaceuticalsBryant Ranch Prepack
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store at 25°C (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
- Not recorded as controlled
- ATC code
- D11AH02 Pimecrolimus
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 November 2018
- Identifiers
- RxCUI 562806DailyMed set ID dc8708ec-16be-4c27-8a5e-bf84723408fe, 6601e43e-ce7d-446a-8568-8e7b24b86f06, ac52a235-1b6f-47a2-b3d9-8d538eeae02f +1NDC 71335-2988, 68682-112, 68462-609 +3Application NDA021302, ANDA211769, ANDA209345
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 tube in 1 carton / 30 g in 1 tube | 68462-609-35 | Glenmark PharmaceuticalsIndia | 29 August 2019 |
| 1 tube in 1 carton / 60 g in 1 tube | 68462-609-65 | Glenmark PharmaceuticalsIndia | 29 August 2019 |
| 1 tube in 1 carton / 100 g in 1 tube | 68462-609-94 | Glenmark PharmaceuticalsIndia | 29 August 2019 |
| 1 tube in 1 carton / 30 g in 1 tube | 68682-110-01 | Oceanside Pharmaceuticals | 26 November 2018 |
| 1 tube in 1 carton / 60 g in 1 tube | 68682-111-02 | Oceanside Pharmaceuticals | 26 November 2018 |
| 1 tube in 1 carton / 100 g in 1 tube | 68682-112-03 | Oceanside Pharmaceuticals | 26 November 2018 |
| 30 g in 1 tube | 0591-2944-30 | Actavis Pharma | 27 December 2018 |
| 60 g in 1 tube | 0591-2944-60 | Actavis Pharma | 27 December 2018 |
| 100 g in 1 tube | 0591-2944-87 | Actavis Pharma | 27 December 2018 |
| 1 tube in 1 carton / 30 g in 1 tube | 71335-2988-1 | Bryant Ranch Prepack | 10 November 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 13 December 2001 | 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
Clinical summary
Pimecrolimus is a calcineurin inhibitor immunosuppressant indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older,. MedsAcross supplies Pimecrolimus 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 PimecrolimusFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Pimecrolimus prescribing information (Oceanside Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Pimecrolimus 1% 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.