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United States · US · US:49230-206_44506bb0-e5f3-2a05-e063-6294a90ab2c9

DELFLEX

In shortageOrange BookUNIISPL

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

Identification

ManufacturerFresenius Medical Care Renal Therapies Group, LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    4923020620
    6 BAG in 1 CARTON (49230-206-20) / 2000 mL in 1 BAG
  • ndc11
    4923020630
    4 BAG in 1 CARTON (49230-206-30) / 3000 mL in 1 BAG
  • ndc11
    4923020632
    4 BAG in 1 CARTON (49230-206-32) / 3000 mL in 1 BAG
  • ndc11
    4923020652
    2 BAG in 1 CARTON (49230-206-52) / 5000 mL in 1 BAG
  • ndc11
    4923020662
    2 BAG in 1 CARTON (49230-206-62) / 6000 mL in 1 BAG

Annotations

UNII (FDA Substance ID)
M4I0D6VV5M
CALCIUM CHLORIDE
RxCUI 221068
Orange Book
N020171
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": "49230-206_44506bb0-e5f3-2a05-e063-6294a90ab2c9",
  "productndc": "49230-206",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "020171",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML",
        "product_no": "001",
        "approval_date": "Aug 19, 1992"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML",
        "product_no": "002",
        "approval_date": "Aug 19, 1992"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML",
        "product_no": "003",
        "approval_date": "Aug 19, 1992"
      }
    ],
    "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": "NDA020171",
  "marketing_category": "NDA",
  "nonproprietary_name": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
  "start_marketing_date": "19920819",
  "active_numerator_strength": "18.4; 1.5; 5.08; 538; 448"
}

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