extraneal

Generic: icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

Labeler: vantive us healthcare llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name extraneal
Generic Name icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
Labeler vantive us healthcare llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAPERITONEAL
Active Ingredients

calcium chloride 25.7 mg/100mL, icodextrin 7.5 g/100mL, magnesium chloride 5.08 mg/100mL, sodium chloride 535 mg/100mL, sodium lactate 448 mg/100mL

Manufacturer
Vantive US Healthcare LLC

Identifiers & Regulatory

Product NDC 0941-0679
Product ID 0941-0679_8412c95a-1cc2-4ae7-baf9-3dc30d5b93a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021321
Listing Expiration 2026-12-31
Marketing Start 2002-12-20

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 09410679
Hyphenated Format 0941-0679

Supplemental Identifiers

RxCUI
1100742 1100746
UNII
M4I0D6VV5M 2NX48Z0A9G 02F3473H9O 451W47IQ8X TU7HW0W0QT

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 extraneal (source: ndc)
Generic Name icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride (source: ndc)
Application Number NDA021321 (source: ndc)
Routes
INTRAPERITONEAL
source: ndc

Resolved Composition

Strengths
  • 25.7 mg/100mL
  • 7.5 g/100mL
  • 5.08 mg/100mL
  • 535 mg/100mL
  • 448 mg/100mL
source: ndc
Packaging
  • 2500 mL in 1 BAG (0941-0679-05)
  • 2000 mL in 1 BAG (0941-0679-06)
  • 2000 mL in 1 BAG (0941-0679-52)
  • 2500 mL in 1 BAG (0941-0679-53)
source: ndc

Packages (4)

0941-0679-05 2500 mL in 1 BAG (0941-0679-05) 0941-0679-06 2000 mL in 1 BAG (0941-0679-06) 0941-0679-52 2000 mL in 1 BAG (0941-0679-52) 0941-0679-53 2500 mL in 1 BAG (0941-0679-53)

Ingredients (5)

calcium chloride (25.7 mg/100mL) icodextrin (7.5 g/100mL) magnesium chloride (5.08 mg/100mL) sodium chloride (535 mg/100mL) sodium lactate (448 mg/100mL)

Linked Drug Pages (1)

EXTRANEAL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAPERITONEAL"], "spl_id": "8412c95a-1cc2-4ae7-baf9-3dc30d5b93a1", "openfda": {"unii": ["M4I0D6VV5M", "2NX48Z0A9G", "02F3473H9O", "451W47IQ8X", "TU7HW0W0QT"], "rxcui": ["1100742", "1100746"], "spl_set_id": ["d5b85158-b0d6-4855-9d07-8d1b3ad9ab71"], "manufacturer_name": ["Vantive US Healthcare LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2500 mL in 1 BAG (0941-0679-05)", "package_ndc": "0941-0679-05", "marketing_start_date": "20021220"}, {"sample": false, "description": "2000 mL in 1 BAG (0941-0679-06)", "package_ndc": "0941-0679-06", "marketing_start_date": "20021220"}, {"sample": false, "description": "2000 mL in 1 BAG (0941-0679-52)", "package_ndc": "0941-0679-52", "marketing_start_date": "20021220"}, {"sample": false, "description": "2500 mL in 1 BAG (0941-0679-53)", "package_ndc": "0941-0679-53", "marketing_start_date": "20021220"}], "brand_name": "EXTRANEAL", "product_id": "0941-0679_8412c95a-1cc2-4ae7-baf9-3dc30d5b93a1", "dosage_form": "INJECTION, 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": "0941-0679", "generic_name": "icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride", "labeler_name": "Vantive US Healthcare LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EXTRANEAL", "active_ingredients": [{"name": "CALCIUM CHLORIDE", "strength": "25.7 mg/100mL"}, {"name": "ICODEXTRIN", "strength": "7.5 g/100mL"}, {"name": "MAGNESIUM CHLORIDE", "strength": "5.08 mg/100mL"}, {"name": "SODIUM CHLORIDE", "strength": "535 mg/100mL"}, {"name": "SODIUM LACTATE", "strength": "448 mg/100mL"}], "application_number": "NDA021321", "marketing_category": "NDA", "marketing_start_date": "20021220", "listing_expiration_date": "20261231"}