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United States · US · US:70550-116_9a10e5d1-3def-4521-bf64-a8e3029a73a2

Minoxidil

Orange BookUNIISPLATC C02DC01

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

Identification

ManufacturerKeranique
CountryUS (United States)
ATC codeC02DC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7055011602
    1 CAN in 1 PACKAGE (70550-116-02) / 60 g in 1 CAN
  • ndc11
    7055011620
    2 CAN in 1 PACKAGE (70550-116-20) / 60 g in 1 CAN

Annotations

UNII (FDA Substance ID)
5965120SH1
MINOXIDIL
RxCUI 6984
Orange Book
A208092
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "5965120SH1",
    "rxcui": "6984",
    "inchikey": "ZFMITUMMTDLWHR-UHFFFAOYSA-N",
    "display_name": "MINOXIDIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "1b54eca8-4a96-1b5e-e063-6394a90a7b94": {
      "match": "brand_token",
      "title": "MINOXIDIL (MINOXIDIL FOAM 5% (WOMENS)) AEROSOL, FOAM [CLARITY COSMETICS INC.]",
      "spl_version": "2",
      "published_date": "2026-06-02"
    }
  },
  "productid": "70550-116_9a10e5d1-3def-4521-bf64-a8e3029a73a2",
  "productndc": "70550-116",
  "dosage_form": "AEROSOL, FOAM",
  "orange_book": {
    "appl_no": "208092",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5%",
        "product_no": "001",
        "approval_date": "Feb 17, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5%",
        "product_no": "002",
        "approval_date": "Jul 27, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "MINOXIDIL",
  "proprietary_name": "Minoxidil",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA208092",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Minoxidil",
  "start_marketing_date": "20240315",
  "active_numerator_strength": "50"
}

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