Calcium Gluconate

In shortageOrange BookUNIISPLATC B05XA19

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeB05XA19

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6521916210
24 BAG in 1 CASE (65219-162-10) / 50 mL in 1 BAG (65219-162-01)

Annotations

UNII (FDA Substance ID)

CZN0MI5R31

CALCIUM GLUCONATE MONOHYDRATE

RxCUI 1298846

Orange Book

N208418

APAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Calcium Chloride Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "CZN0MI5R31",
    "rxcui": "1298846",
    "inchikey": "XLNFVCRGJZBQGX-XRDLMGPZSA-L",
    "display_name": "CALCIUM GLUCONATE MONOHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "a8eee952-54b9-4680-bab6-f90f7e4efb6b": {
      "match": "brand_token",
      "title": "CALCIUM ACETATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "6",
      "published_date": "2026-06-01"
    }
  },
  "productid": "65219-162_3351b72a-aa15-419f-a58c-4df90573d9f9",
  "productndc": "65219-162",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "208418",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1GM/10ML (100MG/ML)",
        "product_no": "001",
        "approval_date": "Jun 15, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "5GM/50ML (100MG/ML)",
        "product_no": "002",
        "approval_date": "Jun 15, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "10GM/100ML (100MG/ML)",
        "product_no": "003",
        "approval_date": "Jun 15, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1GM/50ML (20MG/ML)",
        "product_no": "004",
        "approval_date": "Jun 17, 2021"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2GM/100ML (20MG/ML)",
        "product_no": "005",
        "approval_date": "Jun 17, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CALCIUM GLUCONATE MONOHYDRATE",
  "shortage_reason": "Calcium Chloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Calcium Gluconate",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA208418",
  "marketing_category": "NDA",
  "nonproprietary_name": "Calcium Gluconate",
  "start_marketing_date": "20210617",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code B05XA19.

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