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United States · US · US:0264-8031_87d30389-4483-4d62-a623-d4676e7d16c9

TROMETHAMINE

Orange BookUNIISPLATC B05BB03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerB. Braun Medical Inc.
CountryUS (United States)
ATC codeB05BB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0264803110
    24 BAG in 1 CASE (0264-8031-10) / 500 mL in 1 BAG

Annotations

UNII (FDA Substance ID)
023C2WHX2V
TROMETHAMINE
RxCUI 10865
Orange Book
A211558
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "023C2WHX2V",
    "rxcui": "10865",
    "inchikey": "LENZDBCJOHFCAS-UHFFFAOYSA-N",
    "display_name": "TROMETHAMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "082b1104-502b-47af-95bf-0dbf2422990e": {
      "match": "brand_token",
      "title": "TROMETHAMINE INJECTION, SOLUTION [MILLA PHARMACEUTICALS INC.]",
      "spl_version": "3",
      "published_date": "2026-01-09"
    }
  },
  "productid": "0264-8031_87d30389-4483-4d62-a623-d4676e7d16c9",
  "productndc": "0264-8031",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "211558",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "18GM/500ML (3.6GM/100ML)",
        "product_no": "001",
        "approval_date": "Dec 9, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TROMETHAMINE",
  "proprietary_name": "TROMETHAMINE",
  "active_ingred_unit": "g/100mL",
  "application_number": "ANDA211558",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TROMETHAMINE",
  "start_marketing_date": "20250827",
  "active_numerator_strength": "3.6"
}

Related drugs

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