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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
- ndc114628702001473 mL in 1 BOTTLE (46287-020-01)
- ndc114628702004118 mL in 1 BOTTLE (46287-020-04)
- ndc11462870205010 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
Other records sharing ATC code C03DA01.
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