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United States · US · US:0517-2505_e76a57d0-94d0-4eed-9969-66f2c553ed5c
Potassium Phosphates
In shortageOrange BookSPLATC C03CB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmerican Regent, Inc.
CountryUS (United States)
ATC codeC03CB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11051725052525 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (0517-2505-25) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (0517-2505-01)
Annotations
Orange Book
A216274
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": "0517-2505_e76a57d0-94d0-4eed-9969-66f2c553ed5c",
"productndc": "0517-2505",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "216274",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)",
"product_no": "001",
"approval_date": "Oct 2, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)",
"product_no": "002",
"approval_date": "Oct 2, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)",
"product_no": "003",
"approval_date": "Oct 2, 2023"
}
],
"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": "ANDA216274",
"marketing_category": "ANDA",
"nonproprietary_name": "Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic",
"start_marketing_date": "20231013",
"active_numerator_strength": "236; 224"
}Related drugs
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