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United States · US · US:63304-506_48ee2bd7-f7c9-4bf8-8932-ba9065c64cf3

pentazocine and naloxone

Orange BookUNIISPLATC A06AH

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

Identification

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

Packs · 1

  • ndc11
    6330450601
    100 TABLET in 1 BOTTLE (63304-506-01)

Annotations

UNII (FDA Substance ID)
F850569PQR
NALOXONE HYDROCHLORIDE
RxCUI 203192
Orange Book
A075523
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": "63304-506_48ee2bd7-f7c9-4bf8-8932-ba9065c64cf3",
  "productndc": "63304-506",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075523",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE;EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Mar 17, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NALOXONE HYDROCHLORIDE; PENTAZOCINE",
  "proprietary_name": "pentazocine and naloxone",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA075523",
  "marketing_category": "ANDA",
  "nonproprietary_name": "pentazocine and naloxone",
  "start_marketing_date": "20180731",
  "active_numerator_strength": ".5; 50"
}

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