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United States · US · US:80830-1691_88f63f92-ae9a-4c19-a47e-2cbcab786cc7

POTASSIUM PHOSPHATES

In shortageOrange BookSPLATC C03CB

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

Identification

ManufacturerAmneal Pharmaceuticals Private Limited
CountryUS (United States)
ATC codeC03CB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8083016917
    10 VIAL, SINGLE-DOSE in 1 CARTON (80830-1691-7) / 15 mL in 1 VIAL, SINGLE-DOSE (80830-1691-6)

Annotations

Orange Book
A216344
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": "80830-1691_88f63f92-ae9a-4c19-a47e-2cbcab786cc7",
  "productndc": "80830-1691",
  "dosage_form": "SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "216344",
    "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 10, 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 10, 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 10, 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": "ANDA216344",
  "marketing_category": "ANDA",
  "nonproprietary_name": "potassium phosphate, monobasic potassium phosphate, dibasic injection,",
  "start_marketing_date": "20250709",
  "active_numerator_strength": "236; 224"
}

Related drugs

Other records sharing ATC code C03CB.

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