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United States· US:53746-468_b9016023-7843-48e3-8ff6-2e5a70aa5daf

Clindamycin Palmitate Hydrochloride

A medicinal product containing clindamycin palmitate hydrochloride, registered in United States by Amneal Pharmaceuticals of New York LLC.

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedClindamycin Palmitate HydrochlorideATC—REGISTER NO.US:53746-468_b9016023…PACKS LISTED2CHECKEDJuly 12, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
CLINDAMYCIN PALMITATE HYDROCHLORIDE
Manufacturer
Amneal Pharmaceuticals of New York LLC
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
July 12, 2026

Packs & prices · 2

  • ndc11
    53746-468-19
  • ndc11
    5374646819
    1 BOTTLE in 1 CARTON (53746-468-19) / 100 mL in 1 BOTTLE

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Clindamycin palmitate hydrochloride in 2 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All clindamycin palmitate hydrochloride products

Authorised across Europe · EMA

The same active substance is authorised in 1 EEA country. Names it is sold under:

  • United Kingdom (Northern Ireland) · Clindamycin Penlan Pharmaceuticals

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/e79f92d5-054f-4967-97c6-96e1b7a82245
GET /v1/drugs/e79f92d5-054f-4967-97c6-96e1b7a82245?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "ORAL",
  "source": "ndc",
  "strength": "75",
  "substance": "CLINDAMYCIN PALMITATE HYDROCHLORIDE",
  "productndc": "53746-468",
  "dosage_form": "POWDER, FOR SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/5mL",
  "application_number": "ANDA203513",
  "marketing_category": "ANDA"
}

See everything about clindamycin palmitate hydrochloride.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.