Package 0941-0679-05
Brand: extraneal
Generic: icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloridePackage Facts
Identity
Package NDC
0941-0679-05
Digits Only
0941067905
Product NDC
0941-0679
Description
2500 mL in 1 BAG (0941-0679-05)
Marketing
Marketing Status
Brand
extraneal
Generic
icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
Sample Package
No
Linked Drug Pages (1)
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"}