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United States · US · US:65219-056_935c5395-1f0b-4277-97de-8b1cf1252d1e

Potassium Phosphates

Orange BookUNIISPL

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6521905629
    25 VIAL in 1 TRAY (65219-056-29) / 50 mL in 1 VIAL (65219-056-09)

Annotations

UNII (FDA Substance ID)
CI71S98N1Z
DIBASIC POTASSIUM PHOSPHATE
RxCUI 55018
Orange Book
N212832
APAPAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "CI71S98N1Z",
    "rxcui": "55018",
    "inchikey": "ZPWVASYFFYYZEW-UHFFFAOYSA-L",
    "display_name": "DIBASIC POTASSIUM PHOSPHATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "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": "65219-056_935c5395-1f0b-4277-97de-8b1cf1252d1e",
  "productndc": "65219-056",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "212832",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)",
        "product_no": "001",
        "approval_date": "Nov 26, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)",
        "product_no": "002",
        "approval_date": "Nov 26, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)",
        "product_no": "003",
        "approval_date": "Nov 26, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML)",
        "product_no": "004",
        "approval_date": "May 9, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)",
        "product_no": "005",
        "approval_date": "May 9, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIBASIC POTASSIUM PHOSPHATE; MONOBASIC POTASSIUM PHOSPHATE",
  "proprietary_name": "Potassium Phosphates",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA212832",
  "marketing_category": "NDA",
  "nonproprietary_name": "Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic",
  "start_marketing_date": "20200210",
  "active_numerator_strength": "236; 224"
}

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