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United States · US · US:53489-386_4a668fcd-612e-6944-e063-6394a90a9e2f

MINOXIDIL

Orange BookUNIISPLATC C02DC01

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

Identification

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

Packs · 4

  • ndc11
    5348938601
    100 TABLET in 1 BOTTLE (53489-386-01)
  • ndc11
    5348938603
    250 TABLET in 1 BOTTLE (53489-386-03)
  • ndc11
    5348938605
    500 TABLET in 1 BOTTLE (53489-386-05)
  • ndc11
    5348938610
    1000 TABLET in 1 BOTTLE (53489-386-10)

Annotations

UNII (FDA Substance ID)
5965120SH1
MINOXIDIL
RxCUI 6984
Orange Book
A072709
ABAB
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": "ORAL",
  "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": "53489-386_4a668fcd-612e-6944-e063-6394a90a9e2f",
  "productndc": "53489-386",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "072709",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Dec 14, 1995"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "002",
        "approval_date": "Dec 14, 1995"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MINOXIDIL",
  "proprietary_name": "MINOXIDIL",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA072709",
  "marketing_category": "ANDA",
  "nonproprietary_name": "minoxidil",
  "start_marketing_date": "19951214",
  "active_numerator_strength": "2.5"
}

Related drugs

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