United States· US:0591-0395_cd137b2d-e092-4c37-8c12-ea1ac6297451
Pentazocine and naloxone
A peripheral opioid receptor antagonists product containing pentazocine hydrochloride and naloxone hydrochloride, registered in United States by Actavis Pharma, Inc..
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- Pentazocine hydrochloride and naloxone hydrochloride
- Manufacturer
- Actavis Pharma, Inc.
- Country
- United States (US)
- ATC code
- A06AH
- ATC class
- Peripheral opioid receptor antagonists
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- June 3, 2026
Packs & prices · 1
- ndc110591039501100 TABLET in 1 BOTTLE, PLASTIC (0591-0395-01)
Regulatory notes
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/d5b5034e-fa27-4cf2-89c1-95a2489c7f6b GET /v1/drugs/d5b5034e-fa27-4cf2-89c1-95a2489c7f6b?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.
{
"unii": {
"unii": "F850569PQR",
"rxcui": "203192",
"inchikey": "RGPDIGOSVORSAK-STHHAXOLSA-N",
"display_name": "NALOXONE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"a28450a0-ac93-4235-b9a6-58cdf24773cb": {
"match": "brand_token",
"title": "PENTAZOCINE AND NALOXONE (PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.]",
"spl_version": "28",
"published_date": "2026-01-16"
}
},
"productid": "0591-0395_cd137b2d-e092-4c37-8c12-ea1ac6297451",
"productndc": "0591-0395",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "074736",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.5MG BASE;EQ 50MG BASE",
"product_no": "001",
"approval_date": "Jan 21, 1997"
}
],
"appl_type": "A"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE",
"proprietary_name": "Pentazocine and naloxone",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA074736",
"marketing_category": "ANDA",
"nonproprietary_name": "Pentazocine hydrochloride and naloxone hydrochloride",
"start_marketing_date": "19970521",
"active_numerator_strength": ".5; 50"
}See everything about pentazocine hydrochloride and naloxone 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.