Package 0338-1130-04

Brand: premasol - sulfite-free (amino acid)

Generic: leucine, lysine, isoleucine, valine, histidine, phenylalanine, threonine, methionine, tryptophan, tyrosine, n-acetyl-tyrosine, arginine, proline, alanine, glutamic acide, serine, glycine, aspartic acid, taurine, cysteine hydrochloride
NDC Package

Package Facts

Identity

Package NDC 0338-1130-04
Digits Only 0338113004
Product NDC 0338-1130
Product ID 0338-1130_4083b5c8-ad5f-43f6-ab19-3c87acb2883f
Description

1000 mL in 1 BAG (0338-1130-04)

Marketing

Marketing Status
Marketed Since 2003-06-19
Brand premasol - sulfite-free (amino acid)
Generic leucine, lysine, isoleucine, valine, histidine, phenylalanine, threonine, methionine, tryptophan, tyrosine, n-acetyl-tyrosine, arginine, proline, alanine, glutamic acide, serine, glycine, aspartic acid, taurine, cysteine hydrochloride
Sample Package No

Linked Drug Pages (1)

Premasol - sulfite-free (Amino Acid) ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "4083b5c8-ad5f-43f6-ab19-3c87acb2883f", "openfda": {"nui": ["N0000175780", "M0000922"], "unii": ["OF5P57N2ZX", "94ZLA3W45F", "30KYC7MIAI", "ZT934N0X4W", "3KX376GY7L", "TE7660XO1C", "4QD397987E", "04Y7590D77", "GMW67QNF9C", "TTL6G7LIWZ", "AE28F7PNPL", "47E5O17Y3R", "9DLQ4CIU6V", "452VLY9402", "1EQV5MLY3D", "2ZD004190S", "8DUH1N11BX", "42HK56048U", "HG18B9YRS7"], "rxcui": ["801395", "801398", "801403", "801405"], "spl_set_id": ["9afdcc3e-0d06-47f4-86ca-40da48b2b02b"], "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": "500 mL in 1 BAG (0338-1130-03)", "package_ndc": "0338-1130-03", "marketing_start_date": "20030619"}, {"sample": false, "description": "1000 mL in 1 BAG (0338-1130-04)", "package_ndc": "0338-1130-04", "marketing_start_date": "20030619"}, {"sample": false, "description": "2000 mL in 1 BAG (0338-1130-06)", "package_ndc": "0338-1130-06", "marketing_start_date": "20030619"}], "brand_name": "Premasol - sulfite-free (Amino Acid)", "product_id": "0338-1130_4083b5c8-ad5f-43f6-ab19-3c87acb2883f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amino Acid [EPC]", "Amino Acids [CS]"], "product_ndc": "0338-1130", "generic_name": "LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE", "labeler_name": "Baxter Healthcare Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Premasol - sulfite-free (Amino Acid)", "active_ingredients": [{"name": "ALANINE", "strength": ".54 g/100mL"}, {"name": "ARGININE", "strength": "1.2 g/100mL"}, {"name": "ASPARTIC ACID", "strength": ".32 g/100mL"}, {"name": "CYSTEINE HYDROCHLORIDE", "strength": ".016 g/100mL"}, {"name": "GLUTAMIC ACID", "strength": ".5 g/100mL"}, {"name": "GLYCINE", "strength": ".36 g/100mL"}, {"name": "HISTIDINE", "strength": ".48 g/100mL"}, {"name": "ISOLEUCINE", "strength": ".82 g/100mL"}, {"name": "LEUCINE", "strength": "1.4 g/100mL"}, {"name": "LYSINE ACETATE", "strength": ".82 g/100mL"}, {"name": "METHIONINE", "strength": ".34 g/100mL"}, {"name": "PHENYLALANINE", "strength": ".48 g/100mL"}, {"name": "PROLINE", "strength": ".68 g/100mL"}, {"name": "SERINE", "strength": ".38 g/100mL"}, {"name": "TAURINE", "strength": "25 mg/100mL"}, {"name": "THREONINE", "strength": ".42 g/100mL"}, {"name": "TRYPTOPHAN", "strength": ".2 g/100mL"}, {"name": "TYROSINE", "strength": ".24 g/100mL"}, {"name": "VALINE", "strength": ".78 g/100mL"}], "application_number": "ANDA075880", "marketing_category": "ANDA", "marketing_start_date": "20030619", "listing_expiration_date": "20261231"}