Back to search
🇺🇸

United States · US · US:0615-8579_cdb406b8-353a-42e0-be3d-076d2d789ddc

NALTREXONE HYDROCHLORIDE

Orange BookUNIISPLATC N07BB04

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

Identification

ManufacturerNCS HealthCare of KY, LLC dba Vangard Labs
CountryUS (United States)
ATC codeN07BB04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0615857939
    30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8579-39)

Annotations

UNII (FDA Substance ID)
Z6375YW9SF
NALTREXONE HYDROCHLORIDE
RxCUI 105069
Orange Book
A090356
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": "0615-8579_cdb406b8-353a-42e0-be3d-076d2d789ddc",
  "productndc": "0615-8579",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090356",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Feb 24, 2012"
      }
    ],
    "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": "ANDA090356",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NALTREXONE HYDROCHLORIDE",
  "start_marketing_date": "20120229",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code N07BB04.

Access this data programmatically

Query NALTREXONE HYDROCHLORIDE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.