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United States · US · US:76420-151_d5d43200-9843-10c3-e053-2995a90ad355

Finasteride

In shortageOrange BookUNIISPLATC G04CB01

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

Identification

ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeG04CB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7642015130
    30 TABLET, FILM COATED in 1 BOTTLE (76420-151-30)
  • ndc11
    7642015190
    90 TABLET, FILM COATED in 1 BOTTLE (76420-151-90)

Annotations

UNII (FDA Substance ID)
57GNO57U7G
FINASTERIDE
RxCUI 25025
Orange Book
A203687
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Finasteride Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "57GNO57U7G",
    "rxcui": "25025",
    "inchikey": "DBEPLOCGEIEOCV-WSBQPABSSA-N",
    "display_name": "FINASTERIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "da4e8a51-cf1c-4018-976f-edecc4934a39": {
      "match": "brand_token",
      "title": "FINASTERIDE TABLET, FILM COATED [REMEDYREPACK INC.]",
      "spl_version": "10",
      "published_date": "2026-05-28"
    }
  },
  "productid": "76420-151_d5d43200-9843-10c3-e053-2995a90ad355",
  "productndc": "76420-151",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203687",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Nov 5, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FINASTERIDE",
  "shortage_reason": "Finasteride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Finasteride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203687",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Finasteride",
  "start_marketing_date": "20131105",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code G04CB01.

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