FDA.reportPublic FDA data

TrophAmine

Product NDC
0264-1933
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

Additional Listing Data#

Finished product
Yes
Brand name base
TrophAmine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETYL L-TYROSINE.24 g/100mL
ALANINE.54 g/100mL
ARGININE1.2 g/100mL
ASPARTIC ACID.32 g/100mL
CYSTEINE HYDROCHLORIDE.024 g/100mL
GLUTAMIC ACID.5 g/100mL
GLYCINE.36 g/100mL
HISTIDINE.48 g/100mL
ISOLEUCINE.82 g/100mL
LEUCINE1.4 g/100mL
LYSINE ACETATE1.2 g/100mL
METHIONINE.34 g/100mL
PHENYLALANINE.48 g/100mL
PROLINE.68 g/100mL
SERINE.38 g/100mL
TAURINE.025 g/100mL
THREONINE.42 g/100mL
TRYPTOPHAN.2 g/100mL
TYROSINE.044 g/100mL
VALINE.78 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDA8G610ZO5, OF5P57N2ZX, 94ZLA3W45F, 30KYC7MIAI, ZT934N0X4W, 3KX376GY7L, TE7660XO1C, 4QD397987E, 04Y7590D77, GMW67QNF9C, TTL6G7LIWZ, AE28F7PNPL, 47E5O17Y3R, 9DLQ4CIU6V, 452VLY9402, 1EQV5MLY3D, 2ZD004190S, 8DUH1N11BX, 42HK56048U, HG18B9YRS7
Rxcui800611, 1189640

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0264-1933-102022-03-11C16284748780-1d6a99b39-9908-a426-e053-dadaa90af4c2TrophAmine ® (Amino Acid Injection)
0264-1933-102022-01-28C16284748780-1d6a99b39-9908-a426-e053-dadaa90af4c2TrophAmine ® (Amino Acid Injection)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0264-1933-10TrophAmine500 mL in 1 CONTAINERSOLUTION5009
0264-1933-10TrophAmine12 in 1 CASESOLUTION129

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-1933-10ML - Milliliter0264-19334ccc8c1c-e96a-4c45-a782-a2d6b5255b6c12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-1933TROPHAMINE (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.]9Current NDC, Legacy NDC, 2 package rows20240920_cb6d23ff-3ec5-445a-acbe-f88fd57949bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1189640TrophAmine 10 % Injectable SolutionPSNcb6d23ff-3ec5-445a-acbe-f88fd57949bf9
1189640alanine 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 %]SBDcb6d23ff-3ec5-445a-acbe-f88fd57949bf9
800611alanine 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 SolutionSCDcb6d23ff-3ec5-445a-acbe-f88fd57949bf9
800611Alanine 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 SolutionSYcb6d23ff-3ec5-445a-acbe-f88fd57949bf9
1189640Alanine 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 %]SYcb6d23ff-3ec5-445a-acbe-f88fd57949bf9
800611amino acids 10 % Injectable SolutionSYcb6d23ff-3ec5-445a-acbe-f88fd57949bf9
1189640Trophamine 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 SolutionSYcb6d23ff-3ec5-445a-acbe-f88fd57949bf9
1189640TrophAmine 10 % Injectable SolutionSYcb6d23ff-3ec5-445a-acbe-f88fd57949bf9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-1933-100026419331012 CONTAINER in 1 CASE (0264-1933-10) / 500 mL in 1 CONTAINER12 container2020-10-270000-00-00NoNoCurrent