Medicine
Clindamycin Palmitate Hydrochloride (Pediatric) 75 mg/5 mL powder for oral solution
Clindamycin Palmitate Hydrochloride (Pediatric) 75 mg/5 mL powder for oral solution is a prescription medicine containing Clindamycin palmitate for oral use, marketed by Amneal Pharmaceuticals of New York, 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
Storage as on the product label
Key facts
- Active ingredient (INN)
- Clindamycin palmitate
- Brand
- Clindamycin Palmitate Hydrochloride (Pediatric)
- Strength
- 75 mg/5 mL
- Dosage form
- Powder for oral solution
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Amneal Pharmaceuticals of New York
- Manufacturer
- Amneal Pharmaceuticals of New York
- Origin register
- US FDA, United States
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 April 2024
- Identifiers
- RxCUI 562266DailyMed set ID faf67eb8-1fd7-4b2c-a55b-24ba664c0dceNDC 53746-468Application ANDA203513
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 100 mL in 1 bottle | 53746-468-19 | Amneal Pharmaceuticals of New York | 1 April 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | Approved | 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 Clindamycin palmitate
Clinical summary
Clindamycin palmitate is a lincosamide antibacterial indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. It is available as oral solution and powder for oral solution. MedsAcross supplies Clindamycin palmitate 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 Clindamycin palmitateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Clindamycin Palmitate Hydrochloride (Pediatric) prescribing information (Amneal Pharmaceuticals of New York) · U.S. National Library of Medicine, DailyMed
Need Clindamycin Palmitate Hydrochloride (Pediatric) 75 mg/5 mL powder for oral solution 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.