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United States · US · US:0941-0484_194f41a6-655b-456a-955f-7566eb429b7b

DIANEAL Low Calcium with Dextrose

In shortageOrange BookUNIISPL

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

Identification

ManufacturerVantive US Healthcare LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0941048401
    5000 mL in 1 BAG (0941-0484-01)

Annotations

UNII (FDA Substance ID)
M4I0D6VV5M
CALCIUM CHLORIDE
RxCUI 221068
Orange Book
N017512
ATATAT
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Calcium Chloride Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "M4I0D6VV5M",
    "rxcui": "221068",
    "inchikey": "LLSDKQJKOVVTOJ-UHFFFAOYSA-L",
    "display_name": "CALCIUM CHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAPERITONEAL",
  "spl_meta": {
    "aa268d3f-7389-4f25-801f-5d4825495f08": {
      "match": "brand_token",
      "title": "DIANEAL PD-2 WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [VANTIVE US HEALTHCARE LLC]",
      "spl_version": "37",
      "published_date": "2026-04-23"
    }
  },
  "productid": "0941-0484_194f41a6-655b-456a-955f-7566eb429b7b",
  "productndc": "0941-0484",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "017512",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AT",
        "strength": "25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AT",
        "strength": "25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML",
        "product_no": "005",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AT",
        "strength": "25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML",
        "product_no": "006",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML",
        "product_no": "007",
        "approval_date": "Jul 9, 1984"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML",
        "product_no": "008",
        "approval_date": "Jul 9, 1984"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML",
        "product_no": "009",
        "approval_date": "Jul 9, 1984"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML",
        "product_no": "010",
        "approval_date": "Nov 18, 1985"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML",
        "product_no": "011",
        "approval_date": "Nov 18, 1985"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AT",
        "strength": "18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML",
        "product_no": "012",
        "approval_date": "Jan 10, 1989"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AT",
        "strength": "18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML",
        "product_no": "013",
        "approval_date": "Jul 11, 1990"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML",
        "product_no": "014",
        "approval_date": "Jul 11, 1990"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AT",
        "strength": "18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML",
        "product_no": "015",
        "approval_date": "Jul 11, 1990"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
  "shortage_reason": "Calcium Chloride Injection",
  "shortage_status": "current",
  "proprietary_name": "DIANEAL Low Calcium with Dextrose",
  "active_ingred_unit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
  "application_number": "NDA017512",
  "marketing_category": "NDA",
  "nonproprietary_name": "sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose",
  "start_marketing_date": "19780927",
  "active_numerator_strength": "18.4; 1.5; 5.08; 538; 448"
}

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