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United States · US · US:46163-212_444fd7c1-1ed5-25c7-e063-6394a90a3bfe
Delflex
In shortageOrange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Medical Care de Mexico, S.A. de C.V.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1146163212925 BAG in 1 CARTON (46163-212-92) / 2000 mL in 1 BAG
- ndc1146163212945 BAG in 1 CARTON (46163-212-94) / 2500 mL in 1 BAG
- ndc1146163212955 BAG in 1 CARTON (46163-212-95) / 2000 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": "46163-212_444fd7c1-1ed5-25c7-e063-6394a90a3bfe",
"productndc": "46163-212",
"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": "20240829",
"active_numerator_strength": "18.4; 4.25; 5.08; 538; 448"
}Access this data programmatically
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