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United States · US · US:62135-242_1adc57cf-70f9-75b9-e063-6294a90a0de0

Naltrexone Hydrochloride

Orange BookUNIISPLATC N07BB04

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

Identification

ManufacturerChartwell RX, LLC
CountryUS (United States)
ATC codeN07BB04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6213524230
    30 TABLET, FILM COATED in 1 BOTTLE (62135-242-30)
  • ndc11
    6213524260
    60 TABLET, FILM COATED in 1 BOTTLE (62135-242-60)
  • ndc11
    6213524290
    90 TABLET, FILM COATED in 1 BOTTLE (62135-242-90)

Annotations

UNII (FDA Substance ID)
Z6375YW9SF
NALTREXONE HYDROCHLORIDE
RxCUI 105069
Orange Book
A207905
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": "62135-242_1adc57cf-70f9-75b9-e063-6294a90a0de0",
  "productndc": "62135-242",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "207905",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jul 21, 2017"
      }
    ],
    "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": "ANDA207905",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naltrexone Hydrochloride",
  "start_marketing_date": "20170721",
  "active_numerator_strength": "50"
}

Related drugs

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