Naltrexone Hydrochloride

Orange BookUNIISPLATC N07BB04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeN07BB04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7051843440
30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4344-0)

Annotations

UNII (FDA Substance ID)

Z6375YW9SF

NALTREXONE HYDROCHLORIDE

RxCUI 105069

Orange Book

A075274

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "Z6375YW9SF",
    "rxcui": "105069",
    "inchikey": "RHBRMCOKKKZVRY-ITLPAZOVSA-N",
    "display_name": "NALTREXONE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "fa0b0881-97f3-4ca2-bc15-0954293081db": {
      "match": "brand_token",
      "title": "NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]",
      "spl_version": "13",
      "published_date": "2026-05-20"
    }
  },
  "productid": "70518-4344_4031031d-3b90-1644-e063-6294a90ae5a4",
  "productndc": "70518-4344",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "075274",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "May 26, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NALTREXONE HYDROCHLORIDE",
  "proprietary_name": "Naltrexone Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075274",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naltrexone Hydrochloride",
  "start_marketing_date": "20250520",
  "active_numerator_strength": "50"
}

Related drugs

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