Naltrexone Hydrochloride

Orange BookUNIISPLATC N07BB04

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeN07BB04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009049250
30 TABLET, FILM COATED in 1 BOTTLE (50090-4925-0)

Annotations

UNII (FDA Substance ID)

Z6375YW9SF

NALTREXONE HYDROCHLORIDE

RxCUI 105069

Orange Book

A091205

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": "50090-4925_4242e317-1764-436a-aff6-338a58f1b0a2",
  "productndc": "50090-4925",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "091205",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Aug 17, 2011"
      }
    ],
    "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": "ANDA091205",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naltrexone Hydrochloride",
  "start_marketing_date": "20120118",
  "active_numerator_strength": "50"
}

Related drugs

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