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United States · US · US:64950-127_42dc2391-6bbc-bd57-e063-6294a90a7ef7

HALOG

Orange BookUNIISPLATC D07AD02

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

Identification

ManufacturerGenus Lifesciences Inc.
CountryUS (United States)
ATC codeD07AD02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6495012712
    1 BOTTLE, PLASTIC in 1 CARTON (64950-127-12) / 120 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
SI86V6QNEG
HALCINONIDE
RxCUI 5084
Orange Book
N017823
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "SI86V6QNEG",
    "rxcui": "5084",
    "inchikey": "MUQNGPZZQDCDFT-JNQJZLCISA-N",
    "display_name": "HALCINONIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "484c3224-edd1-db3e-e063-6294a90abc25": {
      "match": "brand_token",
      "title": "HALOG (HALCINONIDE CREAM) CREAM [GENUS LIFESCIENCES INC.]",
      "spl_version": "9",
      "published_date": "2026-01-16"
    }
  },
  "productid": "64950-127_42dc2391-6bbc-bd57-e063-6294a90a7ef7",
  "productndc": "64950-127",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "017823",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AT",
        "strength": "0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HALCINONIDE",
  "proprietary_name": "HALOG",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA017823",
  "marketing_category": "NDA",
  "nonproprietary_name": "Halcinonide Topical",
  "start_marketing_date": "20251117",
  "active_numerator_strength": "1"
}

Related drugs

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