Back to search

United States· US:43386-680_21e7776e-65d0-45fb-a1b2-13f49055ad64

PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

A pentazocine and naloxone product containing pentazocine hydrochloride; naloxone hydrochloride, registered in United States by Lupin Pharmaceuticals,Inc..

ATC N02AD51US 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…normalisedPENTAZOCINE HYDROCHLORIDE AND NALOXON…ATCN02AD51REGISTER NO.US:43386-680_21e7776e…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
PENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Manufacturer
Lupin Pharmaceuticals,Inc.
Country
United States (US)
ATC code
N02AD51
ATC class
Pentazocine and naloxone
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    4338668001
    100 TABLET in 1 BOTTLE (43386-680-01)
  • ndc11
    43386-680-01

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/a1585010-c543-42ba-8d11-7005c1747d7d
GET /v1/drugs/a1585010-c543-42ba-8d11-7005c1747d7d?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": "50; .5",
  "substance": "PENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE",
  "productndc": "43386-680",
  "dosage_form": "TABLET",
  "dea_schedule": "CIV",
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA075735",
  "marketing_category": "ANDA"
}

See everything about pentazocine and naloxone.

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.