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United States · US · US:71335-2419_e0afc24e-ee9e-4321-bf71-85e84772d1e9

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
    7133524191
    30 TABLET, FILM COATED in 1 BOTTLE (71335-2419-1)
  • ndc11
    7133524192
    90 TABLET, FILM COATED in 1 BOTTLE (71335-2419-2)
  • ndc11
    7133524193
    60 TABLET, FILM COATED in 1 BOTTLE (71335-2419-3)
  • ndc11
    7133524194
    45 TABLET, FILM COATED in 1 BOTTLE (71335-2419-4)
  • ndc11
    7133524195
    120 TABLET, FILM COATED in 1 BOTTLE (71335-2419-5)
  • ndc11
    7133524196
    15 TABLET, FILM COATED in 1 BOTTLE (71335-2419-6)
  • ndc11
    7133524197
    100 TABLET, FILM COATED in 1 BOTTLE (71335-2419-7)

Annotations

UNII (FDA Substance ID)
Z6375YW9SF
NALTREXONE HYDROCHLORIDE
RxCUI 105069
Orange Book
A075274
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": "71335-2419_e0afc24e-ee9e-4321-bf71-85e84772d1e9",
  "productndc": "71335-2419",
  "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": "20240215",
  "active_numerator_strength": "50"
}

Related drugs

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