Finasteride

In shortageOrange BookUNIISPLATC G04CB01

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

Identification

ManufacturerDr. Reddy's Laboratories Limited

CountryUS (United States)

ATC codeG04CB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
5511117201
100 TABLET in 1 BOTTLE (55111-172-01)
ndc11
5511117205
500 TABLET in 1 BOTTLE (55111-172-05)
ndc11
5511117230
30 TABLET in 1 BOTTLE (55111-172-30)
ndc11
5511117278
10 BLISTER PACK in 1 CARTON (55111-172-78) / 10 TABLET in 1 BLISTER PACK (55111-172-79)
ndc11
5511117290
90 TABLET in 1 BOTTLE (55111-172-90)

Annotations

UNII (FDA Substance ID)

57GNO57U7G

FINASTERIDE

RxCUI 25025

Orange Book

A076437

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": "55111-172_3e2181d6-f6be-c77e-e3f3-63e26fc35897",
  "productndc": "55111-172",
  "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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