NALTREXONE HYDROCHLORIDE

Orange BookUNIISPLATC N07BB04

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

Identification

ManufacturerAmerican Health Packaging

CountryUS (United States)

ATC codeN07BB04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6808429121
30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-291-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-291-11)

Annotations

UNII (FDA Substance ID)

Z6375YW9SF

NALTREXONE HYDROCHLORIDE

RxCUI 105069

Orange Book

A076264

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": "68084-291_1ef27c71-786e-4f5e-e063-6294a90a7934",
  "productndc": "68084-291",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "076264",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Mar 22, 2002"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Mar 22, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Mar 22, 2002"
      }
    ],
    "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": "ANDA076264",
  "marketing_category": "ANDA",
  "nonproprietary_name": "naltrexone hydrochloride",
  "start_marketing_date": "20130603",
  "active_numerator_strength": "50"
}

Related drugs

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