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United States · US · US:68788-8377_eeb61a34-d202-4426-8035-60d0971daf5d

Finasteride

In shortageOrange BookUNIISPLATC G04CB01

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

Identification

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

Packs · 4

  • ndc11
    6878883771
    100 TABLET, FILM COATED in 1 BOTTLE (68788-8377-1)
  • ndc11
    6878883773
    30 TABLET, FILM COATED in 1 BOTTLE (68788-8377-3)
  • ndc11
    6878883776
    60 TABLET, FILM COATED in 1 BOTTLE (68788-8377-6)
  • ndc11
    6878883779
    90 TABLET, FILM COATED in 1 BOTTLE (68788-8377-9)

Annotations

UNII (FDA Substance ID)
57GNO57U7G
FINASTERIDE
RxCUI 25025
Orange Book
A090061
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": "68788-8377_eeb61a34-d202-4426-8035-60d0971daf5d",
  "productndc": "68788-8377",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090061",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jun 7, 2010"
      }
    ],
    "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": "ANDA090061",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Finasteride",
  "start_marketing_date": "20230228",
  "active_numerator_strength": "5"
}

Related drugs

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