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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

  • ndc11
    0264193310
    12 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"
}

Related drugs

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