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United States · US · US:65145-195_fbbd8380-9848-4862-8c73-2f53fcdf7120
POTASSIUM PHOSPHATES
In shortageOrange BookSPLATC C03CB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCaplin Steriles Limited
CountryUS (United States)
ATC codeC03CB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11651451952525 VIAL, SINGLE-DOSE in 1 CARTON (65145-195-25) / 15 mL in 1 VIAL, SINGLE-DOSE (65145-195-01)
Annotations
Orange Book
A220373
APAPAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Potassium Citrate Tablet, Extended Release
Raw payload (JSON)
{
"route": "INTRAVENOUS",
"spl_meta": {
"ff67f638-5b53-406a-962a-87773a91fc48": {
"match": "brand_token",
"title": "POTASSIUM CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]",
"spl_version": "104",
"published_date": "2026-05-28"
}
},
"productid": "65145-195_fbbd8380-9848-4862-8c73-2f53fcdf7120",
"productndc": "65145-195",
"dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
"orange_book": {
"appl_no": "220373",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)",
"product_no": "001",
"approval_date": "Mar 12, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)",
"product_no": "002",
"approval_date": "Mar 12, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)",
"product_no": "003",
"approval_date": "Mar 12, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC",
"shortage_reason": "Potassium Citrate Tablet, Extended Release",
"shortage_status": "current",
"proprietary_name": "POTASSIUM PHOSPHATES",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "ANDA220373",
"marketing_category": "ANDA",
"nonproprietary_name": "POTASSIUM PHOSPHATES",
"start_marketing_date": "20260316",
"active_numerator_strength": "236; 224"
}Related drugs
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