🇺🇸
United States · US · US:0264-1933_07f53291-419d-4d14-ad81-26f00dc0c474
TrophAmine
Orange BookUNIISPLATC B05XB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerB. Braun Medical Inc.
CountryUS (United States)
ATC codeB05XB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11026419331012 CONTAINER in 1 CASE (0264-1933-10) / 500 mL in 1 CONTAINER
Annotations
UNII (FDA Substance ID)
DA8G610ZO5
ACETYL L-TYROSINE
RxCUI 31005
Orange Book
N019018
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "DA8G610ZO5",
"rxcui": "31005",
"inchikey": "CAHKINHBCWCHCF-JTQLQIEISA-N",
"display_name": "ACETYL L-TYROSINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"cb6d23ff-3ec5-445a-acbe-f88fd57949bf": {
"match": "brand_token",
"title": "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.]",
"spl_version": "9",
"published_date": "2024-09-20"
}
},
"productid": "0264-1933_07f53291-419d-4d14-ad81-26f00dc0c474",
"productndc": "0264-1933",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "019018",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "6% (6GM/100ML)",
"product_no": "001",
"approval_date": "Jul 20, 1984"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10% (10GM/100ML)",
"product_no": "003",
"approval_date": "Sep 7, 1988"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "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",
"proprietary_name": "TrophAmine",
"active_ingred_unit": "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",
"application_number": "NDA019018",
"marketing_category": "NDA",
"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",
"start_marketing_date": "20201027",
"active_numerator_strength": ".24; .54; 1.2; .32; .024; .5; .36; .48; .82; 1.4; 1.2; .34; .48; .68; .38; .025; .42; .2; .044; .78"
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