Package 0990-4178-03
Brand: aminosyn-pf
Generic: isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, proline, serine, taurine, and tyrosinePackage Facts
Identity
Package NDC
0990-4178-03
Digits Only
0990417803
Product NDC
0990-4178
Description
12 BAG in 1 CASE (0990-4178-03) / 500 mL in 1 BAG
Marketing
Marketing Status
Brand
aminosyn-pf
Generic
isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, proline, serine, taurine, and tyrosine
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "488d78ac-3cd2-4593-8968-2992fe59bb49", "openfda": {"nui": ["N0000175780", "M0000922"], "unii": ["OF5P57N2ZX", "94ZLA3W45F", "30KYC7MIAI", "3KX376GY7L", "TE7660XO1C", "4QD397987E", "04Y7590D77", "GMW67QNF9C", "TTL6G7LIWZ", "AE28F7PNPL", "47E5O17Y3R", "9DLQ4CIU6V", "452VLY9402", "1EQV5MLY3D", "2ZD004190S", "8DUH1N11BX", "42HK56048U", "HG18B9YRS7"], "rxcui": ["831426", "831430"], "spl_set_id": ["2d212e10-7e08-4aeb-b63f-dcc927897769"], "pharm_class_cs": ["Amino Acids [CS]"], "pharm_class_epc": ["Amino Acid [EPC]"], "manufacturer_name": ["ICU Medical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BAG in 1 CASE (0990-4178-03) / 500 mL in 1 BAG", "package_ndc": "0990-4178-03", "marketing_start_date": "20211001"}], "brand_name": "Aminosyn-PF", "product_id": "0990-4178_488d78ac-3cd2-4593-8968-2992fe59bb49", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amino Acid [EPC]", "Amino Acids [CS]"], "product_ndc": "0990-4178", "generic_name": "ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, and TYROSINE", "labeler_name": "ICU Medical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aminosyn-PF", "active_ingredients": [{"name": "ALANINE", "strength": "490 mg/100mL"}, {"name": "ARGININE", "strength": "861 mg/100mL"}, {"name": "ASPARTIC ACID", "strength": "370 mg/100mL"}, {"name": "GLUTAMIC ACID", "strength": "576 mg/100mL"}, {"name": "GLYCINE", "strength": "270 mg/100mL"}, {"name": "HISTIDINE", "strength": "220 mg/100mL"}, {"name": "ISOLEUCINE", "strength": "534 mg/100mL"}, {"name": "LEUCINE", "strength": "831 mg/100mL"}, {"name": "LYSINE ACETATE", "strength": "475 mg/100mL"}, {"name": "METHIONINE", "strength": "125 mg/100mL"}, {"name": "PHENYLALANINE", "strength": "300 mg/100mL"}, {"name": "PROLINE", "strength": "570 mg/100mL"}, {"name": "SERINE", "strength": "347 mg/100mL"}, {"name": "TAURINE", "strength": "50 mg/100mL"}, {"name": "THREONINE", "strength": "360 mg/100mL"}, {"name": "TRYPTOPHAN", "strength": "125 mg/100mL"}, {"name": "TYROSINE", "strength": "44 mg/100mL"}, {"name": "VALINE", "strength": "452 mg/100mL"}], "application_number": "NDA019398", "marketing_category": "NDA", "marketing_start_date": "20211001", "listing_expiration_date": "20261231"}