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United States · US · US:17856-1133_51b65bde-7a04-754d-e063-6394a90ad796

SPIRONOLACTONE

In shortageOrange BookUNIISPLATC C03DA01

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

Identification

ManufacturerATLANTIC BIOLOGICALS CORP.
CountryUS (United States)
ATC codeC03DA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    1785611331
    1 SYRINGE in 1 BAG (17856-1133-1) / 2.5 mL in 1 SYRINGE
  • ndc11
    1785611334
    1 SYRINGE in 1 BAG (17856-1133-4) / 2.5 mL in 1 SYRINGE
  • ndc11
    1785611335
    120 SYRINGE in 1 CASE (17856-1133-5) / 1 mL in 1 SYRINGE
  • ndc11
    1785611336
    120 SYRINGE in 1 CASE (17856-1133-6) / 3 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)
27O7W4T232
SPIRONOLACTONE
RxCUI 9997
Orange Book
N209478
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Spironolactone Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "27O7W4T232",
    "rxcui": "9997",
    "inchikey": "LXMSZDCAJNLERA-ZHYRCANASA-N",
    "display_name": "SPIRONOLACTONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3487305c-25a6-4e82-923c-3e4dd638c988": {
      "match": "brand_token",
      "title": "SPIRONOLACTONE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "16",
      "published_date": "2026-06-01"
    }
  },
  "productid": "17856-1133_51b65bde-7a04-754d-e063-6394a90ad796",
  "productndc": "17856-1133",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "209478",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG/5ML",
        "product_no": "001",
        "approval_date": "Aug 4, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SPIRONOLACTONE",
  "shortage_reason": "Spironolactone Tablet",
  "shortage_status": "current",
  "proprietary_name": "SPIRONOLACTONE",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA209478",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "spironolactone",
  "start_marketing_date": "20231031",
  "active_numerator_strength": "25"
}

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