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United States · US · US:0615-8562_4e1dfb0e-d523-48d2-8c82-c80ee2b49800

Finasteride

In shortageOrange BookUNIISPLATC G04CB01

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

Identification

ManufacturerNCS HealthCare of KY, LLC dba Vangard Labs
CountryUS (United States)
ATC codeG04CB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0615856205
    15 TABLET in 1 BLISTER PACK (0615-8562-05)
  • ndc11
    0615856239
    30 TABLET in 1 BLISTER PACK (0615-8562-39)

Annotations

UNII (FDA Substance ID)
57GNO57U7G
FINASTERIDE
RxCUI 25025
Orange Book
A076437
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": "0615-8562_4e1dfb0e-d523-48d2-8c82-c80ee2b49800",
  "productndc": "0615-8562",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076437",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Feb 28, 2007"
      }
    ],
    "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": "ANDA076437",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Finasteride",
  "start_marketing_date": "20070228",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code G04CB01.

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