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United States · US · US:0378-8056_09b49bcc-a3cf-4281-a753-65866b2b8c3b

Halcinonide

Orange BookUNIISPLATC D07AD02

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

Identification

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

Packs · 2

  • ndc11
    0378805649
    1 TUBE in 1 CARTON (0378-8056-49) / 30 g in 1 TUBE
  • ndc11
    0378805660
    1 TUBE in 1 CARTON (0378-8056-60) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
SI86V6QNEG
HALCINONIDE
RxCUI 5084
Orange Book
A211027
AB
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": {
    "aed461bb-e49e-44c4-b42f-b5b261c072a0": {
      "match": "brand_token",
      "title": "HALCINONIDE CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "4",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0378-8056_09b49bcc-a3cf-4281-a753-65866b2b8c3b",
  "productndc": "0378-8056",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "211027",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1%",
        "product_no": "001",
        "approval_date": "Aug 12, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HALCINONIDE",
  "proprietary_name": "Halcinonide",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA211027",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Halcinonide",
  "start_marketing_date": "20190815",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code D07AD02.

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