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United States · US · US:0591-0395_cd137b2d-e092-4c37-8c12-ea1ac6297451

Pentazocine and naloxone

Orange BookUNIISPLATC A06AH

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeA06AH
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0591039501
    100 TABLET in 1 BOTTLE, PLASTIC (0591-0395-01)

Annotations

UNII (FDA Substance ID)
F850569PQR
NALOXONE HYDROCHLORIDE
RxCUI 203192
Orange Book
A074736
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "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"
}

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