Finasteride

In shortageOrange BookUNIISPLATC G04CB01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeG04CB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6362915851
100 TABLET, FILM COATED in 1 BOTTLE (63629-1585-1)
ndc11
6362915852
30 TABLET, FILM COATED in 1 BOTTLE (63629-1585-2)
ndc11
6362915853
60 TABLET, FILM COATED in 1 BOTTLE (63629-1585-3)
ndc11
6362915854
90 TABLET, FILM COATED in 1 BOTTLE (63629-1585-4)
ndc11
6362915855
500 TABLET, FILM COATED in 1 BOTTLE (63629-1585-5)
ndc11
6362915856
180 TABLET, FILM COATED in 1 BOTTLE (63629-1585-6)

Annotations

UNII (FDA Substance ID)

57GNO57U7G

FINASTERIDE

RxCUI 25025

Orange Book

A078341

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": "63629-1585_07ca7b87-0393-4f2d-bddc-143751084103",
  "productndc": "63629-1585",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078341",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Oct 30, 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": "ANDA078341",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Finasteride",
  "start_marketing_date": "20071030",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code G04CB01.

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