delflex

Generic: dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

Labeler: fresenius medical care renal therapies group, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name delflex
Generic Name dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
Labeler fresenius medical care renal therapies group, llc
Dosage Form SOLUTION
Routes
INTRAPERITONEAL
Active Ingredients

calcium chloride 18.4 mg/100mL, dextrose monohydrate 1.5 g/100mL, magnesium chloride 5.08 mg/100mL, sodium chloride 538 mg/100mL, sodium lactate 448 mg/100mL

Manufacturer
Fresenius Medical Care Renal Therapies Group, LLC

Identifiers & Regulatory

Product NDC 49230-206
Product ID 49230-206_44506bb0-e5f3-2a05-e063-6294a90ab2c9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020171
Listing Expiration 2026-12-31
Marketing Start 1992-08-19

Pharmacologic Class

Classes
blood coagulation factor [epc] calcium [cs] calculi dissolution agent [epc] cations divalent [cs] increased coagulation factor activity [pe] increased large intestinal motility [pe] inhibition large intestine fluid/electrolyte absorption [pe] inhibition small intestine fluid/electrolyte absorption [pe] magnesium ion exchange activity [moa] osmotic activity [moa] osmotic laxative [epc] phosphate binder [epc] phosphate chelating activity [moa] stimulation large intestine fluid/electrolyte secretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49230206
Hyphenated Format 49230-206

Supplemental Identifiers

UNII
M4I0D6VV5M TU7HW0W0QT 451W47IQ8X 02F3473H9O LX22YL083G

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name delflex (source: ndc)
Generic Name dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride (source: ndc)
Application Number NDA020171 (source: ndc)
Routes
INTRAPERITONEAL
source: ndc

Resolved Composition

Strengths
  • 18.4 mg/100mL
  • 1.5 g/100mL
  • 5.08 mg/100mL
  • 538 mg/100mL
  • 448 mg/100mL
source: ndc
Packaging
  • 6 BAG in 1 CARTON (49230-206-20) / 2000 mL in 1 BAG
  • 4 BAG in 1 CARTON (49230-206-30) / 3000 mL in 1 BAG
  • 4 BAG in 1 CARTON (49230-206-32) / 3000 mL in 1 BAG
  • 2 BAG in 1 CARTON (49230-206-52) / 5000 mL in 1 BAG
  • 2 BAG in 1 CARTON (49230-206-62) / 6000 mL in 1 BAG
source: ndc

Packages (5)

49230-206-20 6 BAG in 1 CARTON (49230-206-20) / 2000 mL in 1 BAG 49230-206-30 4 BAG in 1 CARTON (49230-206-30) / 3000 mL in 1 BAG 49230-206-32 4 BAG in 1 CARTON (49230-206-32) / 3000 mL in 1 BAG 49230-206-52 2 BAG in 1 CARTON (49230-206-52) / 5000 mL in 1 BAG 49230-206-62 2 BAG in 1 CARTON (49230-206-62) / 6000 mL in 1 BAG

Ingredients (5)

calcium chloride (18.4 mg/100mL) dextrose monohydrate (1.5 g/100mL) magnesium chloride (5.08 mg/100mL) sodium chloride (538 mg/100mL) sodium lactate (448 mg/100mL)

Linked Drug Pages (2)

DELFLEX ndc-match (0.9) DELFLEX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAPERITONEAL"], "spl_id": "44506bb0-e5f3-2a05-e063-6294a90ab2c9", "openfda": {"unii": ["M4I0D6VV5M", "TU7HW0W0QT", "451W47IQ8X", "02F3473H9O", "LX22YL083G"], "spl_set_id": ["bbc5b820-4973-11e2-a192-0002a5d5c51b"], "manufacturer_name": ["Fresenius Medical Care Renal Therapies Group, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BAG in 1 CARTON (49230-206-20)  / 2000 mL in 1 BAG", "package_ndc": "49230-206-20", "marketing_start_date": "19920819"}, {"sample": false, "description": "4 BAG in 1 CARTON (49230-206-30)  / 3000 mL in 1 BAG", "package_ndc": "49230-206-30", "marketing_start_date": "19920819"}, {"sample": false, "description": "4 BAG in 1 CARTON (49230-206-32)  / 3000 mL in 1 BAG", "package_ndc": "49230-206-32", "marketing_start_date": "19920819"}, {"sample": false, "description": "2 BAG in 1 CARTON (49230-206-52)  / 5000 mL in 1 BAG", "package_ndc": "49230-206-52", "marketing_start_date": "19920819"}, {"sample": false, "description": "2 BAG in 1 CARTON (49230-206-62)  / 6000 mL in 1 BAG", "package_ndc": "49230-206-62", "marketing_start_date": "19920819"}], "brand_name": "DELFLEX", "product_id": "49230-206_44506bb0-e5f3-2a05-e063-6294a90ab2c9", "dosage_form": "SOLUTION", "pharm_class": ["Blood Coagulation Factor [EPC]", "Calcium [CS]", "Calculi Dissolution Agent [EPC]", "Cations", "Divalent [CS]", "Increased Coagulation Factor Activity [PE]", "Increased Large Intestinal Motility [PE]", "Increased Large Intestinal Motility [PE]", "Increased Large Intestinal Motility [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]", "Magnesium Ion Exchange Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Osmotic Laxative [EPC]", "Osmotic Laxative [EPC]", "Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "49230-206", "generic_name": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride", "labeler_name": "Fresenius Medical Care Renal Therapies Group, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DELFLEX", "active_ingredients": [{"name": "CALCIUM CHLORIDE", "strength": "18.4 mg/100mL"}, {"name": "DEXTROSE MONOHYDRATE", "strength": "1.5 g/100mL"}, {"name": "MAGNESIUM CHLORIDE", "strength": "5.08 mg/100mL"}, {"name": "SODIUM CHLORIDE", "strength": "538 mg/100mL"}, {"name": "SODIUM LACTATE", "strength": "448 mg/100mL"}], "application_number": "NDA020171", "marketing_category": "NDA", "marketing_start_date": "19920819", "listing_expiration_date": "20261231"}