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United States · US · US:49230-188_4393ca3e-b021-d3a1-e063-6294a90a0d20

DELFLEX

In shortageOrange BookUNIISPL

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

Identification

ManufacturerFresenius Medical Care North America
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4923018852
    2 BAG in 1 CARTON (49230-188-52) / 5000 mL in 1 BAG
  • ndc11
    4923018862
    2 BAG in 1 CARTON (49230-188-62) / 6000 mL in 1 BAG

Annotations

UNII (FDA Substance ID)
M4I0D6VV5M
CALCIUM CHLORIDE
RxCUI 221068
Orange Book
N018883
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": {
    "bbc5b820-4973-11e2-a192-0002a5d5c51b": {
      "match": "brand_token",
      "title": "DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) SOLUTION [FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC]",
      "spl_version": "36",
      "published_date": "2025-11-25"
    }
  },
  "productid": "49230-188_4393ca3e-b021-d3a1-e063-6294a90a0d20",
  "productndc": "49230-188",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "018883",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML",
        "product_no": "001",
        "approval_date": "Nov 30, 1984"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML",
        "product_no": "002",
        "approval_date": "Nov 30, 1984"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML",
        "product_no": "003",
        "approval_date": "Nov 30, 1984"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML",
        "product_no": "004",
        "approval_date": "Nov 30, 1984"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML",
        "product_no": "005",
        "approval_date": "Nov 30, 1984"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML",
        "product_no": "006",
        "approval_date": "Nov 30, 1984"
      }
    ],
    "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": "DELFLEX",
  "active_ingred_unit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
  "application_number": "NDA018883",
  "marketing_category": "NDA",
  "nonproprietary_name": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
  "start_marketing_date": "19841130",
  "active_numerator_strength": "25.7; 1.5; 15.2; 567; 392"
}

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