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United States · US · US:71335-0014_63e4eb6a-b262-44d1-974b-633876a9c563

Naltrexone Hydrochloride

Orange BookUNIISPLATC N07BB04

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN07BB04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    7133500141
    30 TABLET, FILM COATED in 1 BOTTLE (71335-0014-1)
  • ndc11
    7133500142
    90 TABLET, FILM COATED in 1 BOTTLE (71335-0014-2)
  • ndc11
    7133500143
    60 TABLET, FILM COATED in 1 BOTTLE (71335-0014-3)
  • ndc11
    7133500144
    45 TABLET, FILM COATED in 1 BOTTLE (71335-0014-4)
  • ndc11
    7133500145
    120 TABLET, FILM COATED in 1 BOTTLE (71335-0014-5)
  • ndc11
    7133500146
    15 TABLET, FILM COATED in 1 BOTTLE (71335-0014-6)
  • ndc11
    7133500147
    100 TABLET, FILM COATED in 1 BOTTLE (71335-0014-7)

Annotations

UNII (FDA Substance ID)
Z6375YW9SF
NALTREXONE HYDROCHLORIDE
RxCUI 105069
Orange Book
A091205
AB
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": "71335-0014_63e4eb6a-b262-44d1-974b-633876a9c563",
  "productndc": "71335-0014",
  "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

Other records sharing ATC code N07BB04.

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