NDC 0338-9575

Synthamin

Leucine, Isoleucine, Lysine, Valine, Phenylalanine, Histidine, Threonine, Methionine, Tryptophan, Alanine, Arginine, Glycine, Proline, Serine, Tyrosine

Synthamin is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is Leucine; Isoleucine; Lysine; Valine; Phenylalanine; Histidine; Threonine; Methionine; Tryptophan; Alanine; Arginine; Glycine; Proline; Serine; Tyrosine.

• Product ID: 0338-9575_75add2d7-10de-49b8-92cf-7bc4db0faf56
• NDC: 0338-9575
• Product Type: Human Prescription Drug
• Proprietary Name: Synthamin
• Generic Name: Leucine, Isoleucine, Lysine, Valine, Phenylalanine, Histidine, Threonine, Methionine, Tryptophan, Alanine, Arginine, Glycine, Proline, Serine, Tyrosine
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-11-03
• Marketing Category: UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE / UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
• Labeler Name: Baxter Healthcare Corporation
• Substance Name: LEUCINE; ISOLEUCINE; LYSINE; VALINE; PHENYLALANINE; HISTIDINE; THREONINE; METHIONINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; SERINE; TYROSINE
• Active Ingredient Strength: 7 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; mg/1000mL
• Pharm Classes: Amino Acid [EPC],Amino Acids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0338-9575-03

3 BAG in 1 CARTON (0338-9575-03) > 3000 mL in 1 BAG

• Marketing Start Date: 2017-11-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0338-9575-03 [00338957503]

Synthamin INJECTION, SOLUTION

• Marketing Category: Unapproved drug for use in drug shor
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-11-03
• Marketing End Date: 2020-06-30

Drug Details

Active Ingredients

Ingredient	Strength
LEUCINE	7.3 g/1000mL

OpenFDA Data

• SPL SET ID: 3d0063d8-d404-4d4a-abff-8b1adf510042
• Manufacturer:
  • Baxter Healthcare Corporation
• UNII:
  • OF5P57N2ZX
  • 42HK56048U
  • AE28F7PNPL
  • 2ZD004190S
  • 94ZLA3W45F
  • 47E5O17Y3R
  • K3Z4F929H6
  • 9DLQ4CIU6V
  • 04Y7590D77
  • 4QD397987E
  • 452VLY9402
  • GMW67QNF9C
  • HG18B9YRS7
  • TE7660XO1C
  • 8DUH1N11BX

Pharmacological Class

• Amino Acid [EPC]
• Amino Acids [CS]