POTASSIUM PHOSPHATES

In shortageOrange BookSPLATC C03CB

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAmneal Pharmaceuticals Private Limited

CountryUS (United States)

ATC codeC03CB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
8083016922
10 VIAL in 1 CARTON (80830-1692-2) / 50 mL in 1 VIAL (80830-1692-1)
ndc11
8083016925
25 VIAL in 1 CARTON (80830-1692-5) / 50 mL in 1 VIAL (80830-1692-1)

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": "80830-1692_d20a884f-9cba-4621-91ee-6e0ba6e361ca",
  "productndc": "80830-1692",
  "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": "20231023",
  "active_numerator_strength": "236; 224"
}

Related drugs

Other records sharing ATC code C03CB.

Access this data programmatically

Query POTASSIUM PHOSPHATES and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs