Home NDC 0264-1933-10 TrophAmine
Product NDC 0264-1933
Requested package NDC 0264-1933-10
11-digit product format 002641933
Labeler code 0264
Product ID 0264-1933_07f53291-419d-4d14-ad81-26f00dc0c474
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE
Dosage form SOLUTION
Route INTRAVENOUS
Labeler B. Braun Medical Inc.
Application NDA019018
Marketing category NDA
Marketing start 2020-10-27
Substance ACETYL L-TYROSINE; ALANINE; ARGININE; ASPARTIC ACID; CYSTEINE HYDROCHLORIDE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE
Active strength .24; .54; 1.2; .32; .024; .5; .36; .48; .82; 1.4; 1.2; .34; .48; .68; .38; .025; .42; .2; .044; .78 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019018-001 TROPHAMINE AMINO ACIDS 6% (6GM/100ML) INJECTABLE / INJECTION RLD, RS 1984-07-20 N019018-003 TROPHAMINE 10% AMINO ACIDS 10% (10GM/100ML) INJECTABLE / INJECTION RLD, RS 1988-09-07
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 N019018-001 TROPHAMINE 6% (6GM/100ML) INJECTABLE / INJECTION RLD, RS 1984-07-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N019018-003 TROPHAMINE 10% 10% (10GM/100ML) INJECTABLE / INJECTION RLD, RS 1988-09-07 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 TrophAmine ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, AND TAURINE B. Braun Medical Inc. cb6d23ff-3ec5-445a-acbe-f88fd57949bf 2023-11-27 Warnings, Adverse reactions Exact identifier application applno (NDA): 019018 application number: NDA019018 ndc (package): 0264-1933-10 ndc (product): 0264-1933 ndc11 (package): 00264193310
Additional Listing Data#
Finished product Yes
Brand name base TrophAmine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOLEUCINE .24 g/100mL LEUCINE .54 g/100mL LYSINE ACETATE 1.2 g/100mL METHIONINE .32 g/100mL PHENYLALANINE .024 g/100mL THREONINE .5 g/100mL TRYPTOPHAN .36 g/100mL VALINE .48 g/100mL CYSTEINE HYDROCHLORIDE .82 g/100mL HISTIDINE 1.4 g/100mL TYROSINE 1.2 g/100mL ACETYL L-TYROSINE .34 g/100mL ALANINE .48 g/100mL ARGININE .68 g/100mL PROLINE .38 g/100mL SERINE .025 g/100mL GLYCINE .42 g/100mL ASPARTIC ACID .2 g/100mL GLUTAMIC ACID .044 g/100mL TAURINE .78 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 20 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 800611 Internal RxNorm lookup 1189640 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0264-1933-10 TrophAmine 500 mL in 1 CONTAINER SOLUTION 500 9 0264-1933-10 TrophAmine 12 in 1 CASE SOLUTION 12 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0264-1933 TROPHAMINE (ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, AND TAURINE) SOLUTION [B. BRAUN MEDICAL INC.] 9 Current NDC, Legacy NDC, 2 package rows 20240920_cb6d23ff-3ec5-445a-acbe-f88fd57949bf.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1189640 TrophAmine 10 % Injectable Solution PSN cb6d23ff-3ec5-445a-acbe-f88fd57949bf 9 1189640 alanine 5.4 MG/ML / arginine 12 MG/ML / aspartate 3.2 MG/ML / cysteine 0.24 MG/ML / glutamate 5 MG/ML / glycine 3.6 MG/ML / histidine 4.8 MG/ML / isoleucine 8.2 MG/ML / leucine 1.4 MG/ML / lysine 1.2 MG/ML / methionine 3.4 MG/ML / phenylalanine 4.8 MG/ML / proline 6.8 MG/ML / serine 3.8 MG/ML / sodium acetate 0.097 MEQ/ML / sodium chloride 0.003 MEQ/ML / sodium metabisulfite 0.5 MG/ML / taurine 0.25 MG/ML / threonine 4.2 MG/ML / tryptophan 2 MG/ML / tyrosine 2.84 MG/ML / valine 7.8 MG/ML Injectable Solution [Trophamine 10 %] SBD cb6d23ff-3ec5-445a-acbe-f88fd57949bf 9 800611 alanine 5.4 MG/ML / arginine 12 MG/ML / aspartate 3.2 MG/ML / cysteine 0.24 MG/ML / glutamate 5 MG/ML / glycine 3.6 MG/ML / histidine 4.8 MG/ML / isoleucine 8.2 MG/ML / leucine 1.4 MG/ML / lysine 1.2 MG/ML / methionine 3.4 MG/ML / phenylalanine 4.8 MG/ML / proline 6.8 MG/ML / serine 3.8 MG/ML / sodium acetate 0.097 MEQ/ML / sodium chloride 0.003 MEQ/ML / sodium metabisulfite 0.5 MG/ML / taurine 0.25 MG/ML / threonine 4.2 MG/ML / tryptophan 2 MG/ML / tyrosine 2.84 MG/ML / valine 7.8 MG/ML Injectable Solution SCD cb6d23ff-3ec5-445a-acbe-f88fd57949bf 9 800611 Alanine 5.4 MG/ML / Arginine 12 MG/ML / Aspartate 3.2 MG/ML / Cysteine 0.24 MG/ML / Glutamate 5 MG/ML / Glycine 3.6 MG/ML / Histidine 4.8 MG/ML / Isoleucine 8.2 MG/ML / Leucine 1.4 MG/ML / Lysine 1.2 MG/ML / Methionine 3.4 MG/ML / Phenylalanine 4.8 MG/ML / Proline 6.8 MG/ML / Serine 3.8 MG/ML / Sodium Acetate 0.097 MEQ/ML / NaCl 0.003 MEQ/ML / sodium metabisulfite 0.5 MG/ML / Taurine 0.25 MG/ML / Threonine 4.2 MG/ML / Tryptophan 2 MG/ML / Tyrosine 2.84 MG/ML / Valine 7.8 MG/ML Injectable Solution SY cb6d23ff-3ec5-445a-acbe-f88fd57949bf 9 1189640 Alanine 5.4 MG/ML / Arginine 12 MG/ML / Aspartate 3.2 MG/ML / Cysteine 0.24 MG/ML / Glutamate 5 MG/ML / Glycine 3.6 MG/ML / Histidine 4.8 MG/ML / Isoleucine 8.2 MG/ML / Leucine 1.4 MG/ML / Lysine 1.2 MG/ML / Methionine 3.4 MG/ML / Phenylalanine 4.8 MG/ML / Proline 6.8 MG/ML / Serine 3.8 MG/ML / Sodium Acetate 0.097 MEQ/ML / NaCl 0.003 MEQ/ML / sodium metabisulfite 0.5 MG/ML / Taurine 0.25 MG/ML / Threonine 4.2 MG/ML / Tryptophan 2 MG/ML / Tyrosine 2.84 MG/ML / Valine 7.8 MG/ML Injectable Solution [Trophamine 10 %] SY cb6d23ff-3ec5-445a-acbe-f88fd57949bf 9 800611 amino acids 10 % Injectable Solution SY cb6d23ff-3ec5-445a-acbe-f88fd57949bf 9 1189640 Trophamine 10 % (alanine 5.4 MG/ML / arginine 12 MG/ML / aspartate 3.2 MG/ML / cysteine 0.24 MG/ML / glutamate 5 MG/ML / glycine 3.6 MG/ML / histidine 4.8 MG/ML / isoleucine 8.2 MG/ML / leucine 1.4 MG/ML / lysine 1.2 MG/ML / methionine 3.4 MG/ML / phenylalanine 4.8 MG/ML / proline 6.8 MG/ML / serine 3.8 MG/ML / sodium acetate 0.097 MEQ/ML / sodium chloride 0.003 MEQ/ML / sodium metabisulfite 0.5 MG/ML / taurine 0.25 MG/ML / threonine 4.2 MG/ML / tryptophan 2 MG/ML / tyrosine 2.84 MG/ML / valine 7.8 MG/ML) Injectable Solution SY cb6d23ff-3ec5-445a-acbe-f88fd57949bf 9 1189640 TrophAmine 10 % Injectable Solution SY cb6d23ff-3ec5-445a-acbe-f88fd57949bf 9
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0264-1933-10 00264193310 12 CONTAINER in 1 CASE (0264-1933-10) / 500 mL in 1 CONTAINER 12 container 2020-10-27 0000-00-00 No No Current