clinimix

Generic: leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name clinimix
Generic Name leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose
Labeler baxter healthcare corporation
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

alanine 1035 mg/100mL, arginine 575 mg/100mL, dextrose 20 g/100mL, glycine 515 mg/100mL, histidine 240 mg/100mL, isoleucine 300 mg/100mL, leucine 365 mg/100mL, lysine 290 mg/100mL, methionine 200 mg/100mL, phenylalanine 280 mg/100mL, proline 340 mg/100mL, serine 250 mg/100mL, threonine 210 mg/100mL, tryptophan 90 mg/100mL, tyrosine 20 mg/100mL, valine 290 mg/100mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 0338-7013
Product ID 0338-7013_f39f992f-7a22-46f6-9241-f03d349b95d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020734
Listing Expiration 2026-12-31
Marketing Start 2024-07-15

Pharmacologic Class

Established (EPC)
amino acid [epc]
Chemical Structure
amino acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03387013
Hyphenated Format 0338-7013

Supplemental Identifiers

RxCUI
800401 800405 800416 800420 800434 800438 800440 800444
UNII
HG18B9YRS7 AE28F7PNPL OF5P57N2ZX 04Y7590D77 K3Z4F929H6 452VLY9402 42HK56048U IY9XDZ35W2 94ZLA3W45F 8DUH1N11BX TE7660XO1C 2ZD004190S 4QD397987E GMW67QNF9C 9DLQ4CIU6V 47E5O17Y3R
NUI
N0000175780 M0000922

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 clinimix (source: ndc)
Generic Name leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose (source: ndc)
Application Number NDA020734 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1035 mg/100mL
  • 575 mg/100mL
  • 20 g/100mL
  • 515 mg/100mL
  • 240 mg/100mL
  • 300 mg/100mL
  • 365 mg/100mL
  • 290 mg/100mL
  • 200 mg/100mL
  • 280 mg/100mL
  • 340 mg/100mL
  • 250 mg/100mL
  • 210 mg/100mL
  • 90 mg/100mL
  • 20 mg/100mL
source: ndc
Packaging
  • 6 BAG in 1 CARTON (0338-7013-06) / 1000 mL in 1 BAG (0338-7013-01)
source: ndc

Packages (1)

0338-7013-06 6 BAG in 1 CARTON (0338-7013-06) / 1000 mL in 1 BAG (0338-7013-01)

Ingredients (16)

alanine (1035 mg/100mL) arginine (575 mg/100mL) dextrose (20 g/100mL) glycine (515 mg/100mL) histidine (240 mg/100mL) isoleucine (300 mg/100mL) leucine (365 mg/100mL) lysine (290 mg/100mL) methionine (200 mg/100mL) phenylalanine (280 mg/100mL) proline (340 mg/100mL) serine (250 mg/100mL) threonine (210 mg/100mL) tryptophan (90 mg/100mL) tyrosine (20 mg/100mL) valine (290 mg/100mL)

Linked Drug Pages (1)

CLINIMIX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "f39f992f-7a22-46f6-9241-f03d349b95d9", "openfda": {"nui": ["N0000175780", "M0000922"], "unii": ["HG18B9YRS7", "AE28F7PNPL", "OF5P57N2ZX", "04Y7590D77", "K3Z4F929H6", "452VLY9402", "42HK56048U", "IY9XDZ35W2", "94ZLA3W45F", "8DUH1N11BX", "TE7660XO1C", "2ZD004190S", "4QD397987E", "GMW67QNF9C", "9DLQ4CIU6V", "47E5O17Y3R"], "rxcui": ["800401", "800405", "800416", "800420", "800434", "800438", "800440", "800444"], "spl_set_id": ["dccff103-8695-400c-a15d-cc2fd078760a"], "pharm_class_cs": ["Amino Acids [CS]"], "pharm_class_epc": ["Amino Acid [EPC]"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BAG in 1 CARTON (0338-7013-06)  / 1000 mL in 1 BAG (0338-7013-01)", "package_ndc": "0338-7013-06", "marketing_start_date": "20240715"}], "brand_name": "CLINIMIX", "product_id": "0338-7013_f39f992f-7a22-46f6-9241-f03d349b95d9", "dosage_form": "INJECTION", "pharm_class": ["Amino Acid [EPC]", "Amino Acids [CS]"], "product_ndc": "0338-7013", "generic_name": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLINIMIX", "active_ingredients": [{"name": "ALANINE", "strength": "1035 mg/100mL"}, {"name": "ARGININE", "strength": "575 mg/100mL"}, {"name": "DEXTROSE", "strength": "20 g/100mL"}, {"name": "GLYCINE", "strength": "515 mg/100mL"}, {"name": "HISTIDINE", "strength": "240 mg/100mL"}, {"name": "ISOLEUCINE", "strength": "300 mg/100mL"}, {"name": "LEUCINE", "strength": "365 mg/100mL"}, {"name": "LYSINE", "strength": "290 mg/100mL"}, {"name": "METHIONINE", "strength": "200 mg/100mL"}, {"name": "PHENYLALANINE", "strength": "280 mg/100mL"}, {"name": "PROLINE", "strength": "340 mg/100mL"}, {"name": "SERINE", "strength": "250 mg/100mL"}, {"name": "THREONINE", "strength": "210 mg/100mL"}, {"name": "TRYPTOPHAN", "strength": "90 mg/100mL"}, {"name": "TYROSINE", "strength": "20 mg/100mL"}, {"name": "VALINE", "strength": "290 mg/100mL"}], "application_number": "NDA020734", "marketing_category": "NDA", "marketing_start_date": "20240715", "listing_expiration_date": "20261231"}