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United States · US · US:46287-020_341fea14-cdc7-4c75-b1ca-706e90dc0128

CaroSpir

In shortageOrange BookUNIISPLATC C03DA01

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

Identification

ManufacturerCMP Pharma, Inc.
CountryUS (United States)
ATC codeC03DA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4628702001
    473 mL in 1 BOTTLE (46287-020-01)
  • ndc11
    4628702004
    118 mL in 1 BOTTLE (46287-020-04)
  • ndc11
    4628702050
    10 CUP, UNIT-DOSE in 1 CARTON (46287-020-50) / 5 mL in 1 CUP, UNIT-DOSE

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": {
    "c4f70a04-7d89-4b73-8b02-17d43471bf08": {
      "match": "brand_token",
      "title": "CAROSPIR SUSPENSION [CMP PHARMA, INC.]",
      "spl_version": "7",
      "published_date": "2025-12-24"
    }
  },
  "productid": "46287-020_341fea14-cdc7-4c75-b1ca-706e90dc0128",
  "productndc": "46287-020",
  "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": "CaroSpir",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA209478",
  "marketing_category": "NDA",
  "nonproprietary_name": "CaroSpir",
  "start_marketing_date": "20170804",
  "active_numerator_strength": "25"
}

Related drugs

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