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United States · US · US:57483-530_36bf641f-2d8d-44ee-a5db-36d1135eebeb

Regoxidine

Orange BookUNIISPLATC C02DC01

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

Identification

ManufacturerInnovus Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC02DC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5748353031
    3 CAN in 1 PACKAGE (57483-530-31) / 60 g in 1 CAN

Annotations

UNII (FDA Substance ID)
5965120SH1
MINOXIDIL
RxCUI 6984
Orange Book
A209074
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": {
    "9c06c34d-5a09-47ed-b969-cc81f4ed61ab": {
      "match": "brand_token",
      "title": "REGOXIDINE (FOR WOMEN) (MINOXIDIL) AEROSOL, FOAM [INNOVUS PHARMACEUTICALS, INC.]",
      "spl_version": "4",
      "published_date": "2026-01-21"
    }
  },
  "productid": "57483-530_36bf641f-2d8d-44ee-a5db-36d1135eebeb",
  "productndc": "57483-530",
  "dosage_form": "AEROSOL, FOAM",
  "orange_book": {
    "appl_no": "209074",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5%",
        "product_no": "001",
        "approval_date": "Dec 31, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5%",
        "product_no": "002",
        "approval_date": "Apr 22, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "MINOXIDIL",
  "proprietary_name": "Regoxidine",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA209074",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Minoxidil",
  "start_marketing_date": "20190102",
  "active_numerator_strength": "50"
}

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