CALCIUM GLUCONATE

In shortageOrange BookUNIISPLATC B05XA19

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

Identification

ManufacturerAmneal Pharmaceuticals Private Limited

CountryUS (United States)

ATC codeB05XA19

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
8083023622
12 POUCH in 1 CARTON (80830-2362-2) / 1 BAG in 1 POUCH / 50 mL in 1 BAG
ndc11
8083023629
24 POUCH in 1 CARTON (80830-2362-9) / 1 BAG in 1 POUCH / 50 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

CZN0MI5R31

CALCIUM GLUCONATE MONOHYDRATE

RxCUI 1298846

Orange Book

A217174

APAP

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": "80830-2362_2bd614b6-02ce-49e3-86e2-dfaec7a13e04",
  "productndc": "80830-2362",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "217174",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "1GM/50ML (20MG/ML)",
        "product_no": "001",
        "approval_date": "Sep 5, 2023"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "2GM/100ML (20MG/ML)",
        "product_no": "002",
        "approval_date": "Sep 5, 2023"
      }
    ],
    "appl_type": "A"
  },
  "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": "ANDA217174",
  "marketing_category": "ANDA",
  "nonproprietary_name": "calcium gluconate",
  "start_marketing_date": "20230908",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code B05XA19.

Access this data programmatically

Query CALCIUM GLUCONATE 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