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United States · US · US:69489-212_e5d4b4fa-1951-4fa8-9677-acb97b10c087

ZILXI

Orange BookUNIISPLATC A01AB23

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

Identification

ManufacturerJourney Medical Corporation
CountryUS (United States)
ATC codeA01AB23
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6948921203
    1 CAN in 1 CARTON (69489-212-03) / 3 g in 1 CAN
  • ndc11
    6948921230
    1 CAN in 1 CARTON (69489-212-30) / 30 g in 1 CAN

Annotations

UNII (FDA Substance ID)
0020414E5U
MINOCYCLINE HYDROCHLORIDE
RxCUI 6979
Orange Book
N213690
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "0020414E5U",
    "rxcui": "6979",
    "inchikey": "GLMUAFMGXXHGLU-VQAITOIOSA-N",
    "display_name": "MINOCYCLINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "cbffa96e-2446-43cf-ba5e-38c645302afd": {
      "match": "brand_token",
      "title": "ZILXI (MINOCYCLINE) AEROSOL, FOAM [JOURNEY MEDICAL CORPORATION]",
      "spl_version": "3",
      "published_date": "2024-02-12"
    }
  },
  "productid": "69489-212_e5d4b4fa-1951-4fa8-9677-acb97b10c087",
  "productndc": "69489-212",
  "dosage_form": "AEROSOL, FOAM",
  "orange_book": {
    "appl_no": "213690",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1.5% BASE",
        "product_no": "001",
        "approval_date": "May 28, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MINOCYCLINE HYDROCHLORIDE",
  "proprietary_name": "ZILXI",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA213690",
  "marketing_category": "NDA",
  "nonproprietary_name": "Minocycline",
  "start_marketing_date": "20221001",
  "active_numerator_strength": "15"
}

Related drugs

Other records sharing ATC code A01AB23.

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