Home NDC 0338-0644 Travasol
Product NDC 0338-0644
11-digit product format 003380644
Labeler code 0338
Product ID 0338-0644_e0279078-016d-48fd-8de1-c894422b33ff
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Leucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine
Dosage form INJECTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application NDA018931
Marketing category NDA
Marketing start 1984-08-23
Substance ALANINE; ARGININE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE HYDROCHLORIDE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE
Active strength 2.07; 1.15; 1.03; 480; 600; 730; 580; 400; 560; 680; 500; 420; 180; 40; 580 g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
Pharmacologic classes Amino Acid [EPC], Amino Acids [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018931-001 TRAVASOL 5.5% IN PLASTIC CONTAINER AMINO ACIDS 5.5% (5.5GM/100ML) INJECTABLE / INJECTION 1984-08-23 N018931-002 TRAVASOL 8.5% IN PLASTIC CONTAINER AMINO ACIDS 8.5% (8.5GM/100ML) INJECTABLE / INJECTION 1984-08-23 N018931-003 TRAVASOL 10% IN PLASTIC CONTAINER AMINO ACIDS 10% (10MG/100ML) INJECTABLE / INJECTION 1984-08-23
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N018931-001 TRAVASOL 5.5% IN PLASTIC CONTAINER 5.5% (5.5GM/100ML) INJECTABLE / INJECTION 1984-08-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N018931-002 TRAVASOL 8.5% IN PLASTIC CONTAINER 8.5% (8.5GM/100ML) INJECTABLE / INJECTION 1984-08-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N018931-003 TRAVASOL 10% IN PLASTIC CONTAINER 10% (10MG/100ML) INJECTABLE / INJECTION 1984-08-23 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Travasol LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE Baxter Healthcare Corporation 8543b5be-0f43-4891-9e56-d7c39fe839b5 2020-10-07 Warnings, Adverse reactions Exact identifier application applno (NDA): 018931 application number: NDA018931 ndc (product): 0338-0644
Additional Listing Data#
Finished product Yes
Brand name base Travasol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEUCINE 2.07 g/100mL PHENYLALANINE 1.15 g/100mL LYSINE HYDROCHLORIDE 1.03 g/100mL METHIONINE 480 mg/100mL ISOLEUCINE 600 mg/100mL VALINE 730 mg/100mL HISTIDINE 580 mg/100mL THREONINE 400 mg/100mL TRYPTOPHAN 560 mg/100mL ALANINE 680 mg/100mL GLYCINE 500 mg/100mL ARGININE 420 mg/100mL PROLINE 180 mg/100mL TYROSINE 40 mg/100mL SERINE 580 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 15 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 801644 Internal RxNorm lookup 801648 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0338-0644-03 Travasol 500 mL in 1 BAG INJECTION 500 16 0338-0644-04 Travasol 1000 mL in 1 BAG INJECTION 1000 16 0338-0644-06 Travasol 2000 mL in 1 BAG INJECTION 2000 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALANINE ACTIVE INGREDIENT OF5P57N2ZX TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 ARGININE ACTIVE INGREDIENT 94ZLA3W45F TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 GLYCINE ACTIVE INGREDIENT TE7660XO1C TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 HISTIDINE ACTIVE INGREDIENT 4QD397987E TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 ISOLEUCINE ACTIVE INGREDIENT 04Y7590D77 TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 LEUCINE ACTIVE INGREDIENT GMW67QNF9C TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 LYSINE HYDROCHLORIDE ACTIVE INGREDIENT JNJ23Q2COM TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 METHIONINE ACTIVE INGREDIENT AE28F7PNPL TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 PHENYLALANINE ACTIVE INGREDIENT 47E5O17Y3R TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 PROLINE ACTIVE INGREDIENT 9DLQ4CIU6V TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 SERINE ACTIVE INGREDIENT 452VLY9402 TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 THREONINE ACTIVE INGREDIENT 2ZD004190S TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 TRYPTOPHAN ACTIVE INGREDIENT 8DUH1N11BX TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 TYROSINE ACTIVE INGREDIENT 42HK56048U TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 VALINE ACTIVE INGREDIENT HG18B9YRS7 TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 ALANINE ACTIVE MOIETY OF5P57N2ZX TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 ARGININE ACTIVE MOIETY 94ZLA3W45F TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 GLYCINE ACTIVE MOIETY TE7660XO1C TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 HISTIDINE ACTIVE MOIETY 4QD397987E TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 ISOLEUCINE ACTIVE MOIETY 04Y7590D77 TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 LEUCINE ACTIVE MOIETY GMW67QNF9C TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 LYSINE ACTIVE MOIETY K3Z4F929H6 TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 METHIONINE ACTIVE MOIETY AE28F7PNPL TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 PHENYLALANINE ACTIVE MOIETY 47E5O17Y3R TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 PROLINE ACTIVE MOIETY 9DLQ4CIU6V TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 SERINE ACTIVE MOIETY 452VLY9402 TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 THREONINE ACTIVE MOIETY 2ZD004190S TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 TRYPTOPHAN ACTIVE MOIETY 8DUH1N11BX TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 TYROSINE ACTIVE MOIETY 42HK56048U TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 VALINE ACTIVE MOIETY HG18B9YRS7 TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 ACETIC ACID INACTIVE INGREDIENT Q40Q9N063P TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5 WATER INACTIVE INGREDIENT 059QF0KO0R TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-0644 TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] 16 Current NDC, Legacy NDC, 3 package rows 20250209_8543b5be-0f43-4891-9e56-d7c39fe839b5.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 801648 Travasol 10 % Injectable Solution PSN 8543b5be-0f43-4891-9e56-d7c39fe839b5 16 801648 alanine 20.7 MG/ML / arginine 11.5 MG/ML / glycine 10.3 MG/ML / histidine 4.8 MG/ML / isoleucine 6 MG/ML / leucine 7.3 MG/ML / lysine 5.8 MG/ML / methionine 4 MG/ML / phenylalanine 5.6 MG/ML / proline 6.8 MG/ML / serine 5 MG/ML / threonine 4.2 MG/ML / tryptophan 1.8 MG/ML / tyrosine 0.4 MG/ML / valine 5.8 MG/ML Injectable Solution [Travasol 10] SBD 8543b5be-0f43-4891-9e56-d7c39fe839b5 16 801644 alanine 20.7 MG/ML / arginine 11.5 MG/ML / glycine 10.3 MG/ML / histidine 4.8 MG/ML / isoleucine 6 MG/ML / leucine 7.3 MG/ML / lysine 5.8 MG/ML / methionine 4 MG/ML / phenylalanine 5.6 MG/ML / proline 6.8 MG/ML / serine 5 MG/ML / threonine 4.2 MG/ML / tryptophan 1.8 MG/ML / tyrosine 0.4 MG/ML / valine 5.8 MG/ML Injectable Solution SCD 8543b5be-0f43-4891-9e56-d7c39fe839b5 16 801648 Travasol 10 % Injectable Solution SY 8543b5be-0f43-4891-9e56-d7c39fe839b5 16
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0338-0644-03 00338064403 500 mL in 1 BAG (0338-0644-03) 500 ml 1984-08-23 0000-00-00 No No Current 0338-0644-04 00338064404 1000 mL in 1 BAG (0338-0644-04) 1000 ml 1984-08-23 0000-00-00 No No Current 0338-0644-06 00338064406 2000 mL in 1 BAG (0338-0644-06) 2000 ml 1984-08-23 0000-00-00 No No Current