Package 0338-7028-04
Brand: clinimix e
Generic: leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrosePackage Facts
Identity
Package NDC
0338-7028-04
Digits Only
0338702804
Product NDC
0338-7028
Description
4 BAG in 1 CARTON (0338-7028-04) / 2000 mL in 1 BAG (0338-7028-01)
Marketing
Marketing Status
Brand
clinimix e
Generic
leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "dc7ce216-a4a9-41cf-80e3-5e901b8cecdf", "openfda": {"nui": ["N0000175780", "M0000922"], "unii": ["HG18B9YRS7", "04Y7590D77", "02F3473H9O", "47E5O17Y3R", "AE28F7PNPL", "CI71S98N1Z", "8DUH1N11BX", "2ZD004190S", "452VLY9402", "9DLQ4CIU6V", "OF5P57N2ZX", "42HK56048U", "GMW67QNF9C", "M4I0D6VV5M", "K3Z4F929H6", "IY9XDZ35W2", "94ZLA3W45F", "451W47IQ8X", "TE7660XO1C", "4QD397987E", "4550K0SC9B"], "rxcui": ["800998", "801000", "801010", "801012", "801019", "801021", "801029", "801031", "1090635", "1090639"], "spl_set_id": ["8469d6fb-d6ef-476f-8cc3-0905192de0a8"], "pharm_class_cs": ["Amino Acids [CS]"], "pharm_class_epc": ["Amino Acid [EPC]"], "manufacturer_name": ["Baxter Healthcare Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BAG in 1 CARTON (0338-7028-04) / 2000 mL in 1 BAG (0338-7028-01)", "package_ndc": "0338-7028-04", "marketing_start_date": "20240715"}], "brand_name": "CLINIMIX E", "product_id": "0338-7028_dc7ce216-a4a9-41cf-80e3-5e901b8cecdf", "dosage_form": "INJECTION", "pharm_class": ["Amino Acid [EPC]", "Amino Acids [CS]", "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]", "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 Laxative [EPC]", "Osmotic Laxative [EPC]", "Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "0338-7028", "generic_name": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose", "labeler_name": "Baxter Healthcare Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLINIMIX E", "active_ingredients": [{"name": "ALANINE", "strength": "880 mg/100mL"}, {"name": "ARGININE", "strength": "489 mg/100mL"}, {"name": "CALCIUM CHLORIDE", "strength": "33 mg/100mL"}, {"name": "DEXTROSE", "strength": "10 g/100mL"}, {"name": "GLYCINE", "strength": "438 mg/100mL"}, {"name": "HISTIDINE", "strength": "204 mg/100mL"}, {"name": "ISOLEUCINE", "strength": "255 mg/100mL"}, {"name": "LEUCINE", "strength": "311 mg/100mL"}, {"name": "LYSINE", "strength": "247 mg/100mL"}, {"name": "MAGNESIUM CHLORIDE", "strength": "51 mg/100mL"}, {"name": "METHIONINE", "strength": "170 mg/100mL"}, {"name": "PHENYLALANINE", "strength": "238 mg/100mL"}, {"name": "POTASSIUM PHOSPHATE, DIBASIC", "strength": "261 mg/100mL"}, {"name": "PROLINE", "strength": "289 mg/100mL"}, {"name": "SERINE", "strength": "213 mg/100mL"}, {"name": "SODIUM ACETATE", "strength": "297 mg/100mL"}, {"name": "SODIUM CHLORIDE", "strength": "77 mg/100mL"}, {"name": "THREONINE", "strength": "179 mg/100mL"}, {"name": "TRYPTOPHAN", "strength": "77 mg/100mL"}, {"name": "TYROSINE", "strength": "17 mg/100mL"}, {"name": "VALINE", "strength": "247 mg/100mL"}], "application_number": "NDA020678", "marketing_category": "NDA", "marketing_start_date": "20240715", "listing_expiration_date": "20261231"}