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United States· US:68382-396_6ad04728-e1b6-4851-9614-1322607ce238

SODIUM PHENYLACETATE AND SODIUM BENZOATE

A medicinal product containing sodium phenylacetate; sodium benzoate, registered in United States by Zydus Pharmaceuticals USA Inc..

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…normalisedSODIUM PHENYLACETATE AND SODIUM BENZO…ATC—REGISTER NO.US:68382-396_6ad04728…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
SODIUM PHENYLACETATE; SODIUM BENZOATE
Manufacturer
Zydus Pharmaceuticals USA Inc.
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    68382-396-01
  • ndc11
    6838239601
    1 VIAL in 1 CARTON (68382-396-01) / 50 mL in 1 VIAL

Regulatory notes

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

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/cdd41b7f-ebae-40da-9590-831471882273
GET /v1/drugs/cdd41b7f-ebae-40da-9590-831471882273?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": "INTRAVENOUS",
  "source": "ndc",
  "strength": "100; 100",
  "substance": "SODIUM PHENYLACETATE; SODIUM BENZOATE",
  "productndc": "68382-396",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "dea_schedule": null,
  "strength_unit": "mg/mL; mg/mL",
  "application_number": "ANDA205880",
  "marketing_category": "ANDA"
}

See everything about sodium phenylacetate; sodium benzoate.

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.