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 880 mg/100mL, arginine 489 mg/100mL, dextrose 5 g/100mL, glycine 438 mg/100mL, histidine 204 mg/100mL, isoleucine 255 mg/100mL, leucine 311 mg/100mL, lysine 247 mg/100mL, methionine 170 mg/100mL, phenylalanine 238 mg/100mL, proline 289 mg/100mL, serine 213 mg/100mL, threonine 179 mg/100mL, tryptophan 77 mg/100mL, tyrosine 17 mg/100mL, valine 247 mg/100mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 0338-7003
Product ID 0338-7003_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 03387003
Hyphenated Format 0338-7003

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
  • 880 mg/100mL
  • 489 mg/100mL
  • 5 g/100mL
  • 438 mg/100mL
  • 204 mg/100mL
  • 255 mg/100mL
  • 311 mg/100mL
  • 247 mg/100mL
  • 170 mg/100mL
  • 238 mg/100mL
  • 289 mg/100mL
  • 213 mg/100mL
  • 179 mg/100mL
  • 77 mg/100mL
  • 17 mg/100mL
source: ndc
Packaging
  • 4 BAG in 1 CARTON (0338-7003-04) / 2000 mL in 1 BAG (0338-7003-01)
source: ndc

Packages (1)

0338-7003-04 4 BAG in 1 CARTON (0338-7003-04) / 2000 mL in 1 BAG (0338-7003-01)

Ingredients (16)

alanine (880 mg/100mL) arginine (489 mg/100mL) dextrose (5 g/100mL) glycine (438 mg/100mL) histidine (204 mg/100mL) isoleucine (255 mg/100mL) leucine (311 mg/100mL) lysine (247 mg/100mL) methionine (170 mg/100mL) phenylalanine (238 mg/100mL) proline (289 mg/100mL) serine (213 mg/100mL) threonine (179 mg/100mL) tryptophan (77 mg/100mL) tyrosine (17 mg/100mL) valine (247 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": "4 BAG in 1 CARTON (0338-7003-04)  / 2000 mL in 1 BAG (0338-7003-01)", "package_ndc": "0338-7003-04", "marketing_start_date": "20240715"}], "brand_name": "CLINIMIX", "product_id": "0338-7003_f39f992f-7a22-46f6-9241-f03d349b95d9", "dosage_form": "INJECTION", "pharm_class": ["Amino Acid [EPC]", "Amino Acids [CS]"], "product_ndc": "0338-7003", "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": "880 mg/100mL"}, {"name": "ARGININE", "strength": "489 mg/100mL"}, {"name": "DEXTROSE", "strength": "5 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": "METHIONINE", "strength": "170 mg/100mL"}, {"name": "PHENYLALANINE", "strength": "238 mg/100mL"}, {"name": "PROLINE", "strength": "289 mg/100mL"}, {"name": "SERINE", "strength": "213 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": "NDA020734", "marketing_category": "NDA", "marketing_start_date": "20240715", "listing_expiration_date": "20261231"}