Back to search
🇺🇸

United States · US · US:50090-7852_067a71d1-2d8f-4ca2-acb9-06718a5eb8c6

Dutasteride

Orange BookUNIISPLATC G04CB02

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeG04CB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5009078520
    30 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-7852-0)
  • ndc11
    5009078521
    90 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-7852-1)

Annotations

UNII (FDA Substance ID)
O0J6XJN02I
DUTASTERIDE
RxCUI 228790
Orange Book
A209909
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "O0J6XJN02I",
    "rxcui": "228790",
    "inchikey": "JWJOTENAMICLJG-QWBYCMEYSA-N",
    "display_name": "DUTASTERIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "74f29982-2317-4d31-a324-fe99bd134c31": {
      "match": "brand_token",
      "title": "DUTASTERIDE CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK]",
      "spl_version": "107",
      "published_date": "2026-06-01"
    }
  },
  "productid": "50090-7852_067a71d1-2d8f-4ca2-acb9-06718a5eb8c6",
  "productndc": "50090-7852",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "209909",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Nov 21, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DUTASTERIDE",
  "proprietary_name": "Dutasteride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209909",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dutasteride",
  "start_marketing_date": "20171128",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code G04CB02.

Access this data programmatically

Query Dutasteride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.