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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

  • ndc11
    6514519525
    25 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

Other records sharing ATC code C03CB.

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