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United States · US · US:0409-1593_66406bf4-d7c7-4e73-9675-defa737c3b75

THAM

Orange BookUNIISPLATC B05BB03

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

Identification

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

Packs · 1

  • ndc11
    0409159304
    6 BOTTLE, GLASS in 1 CASE (0409-1593-04) / 500 mL in 1 BOTTLE, GLASS (0409-1593-14)

Annotations

UNII (FDA Substance ID)
023C2WHX2V
TROMETHAMINE
RxCUI 10865
Orange Book
N013025
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": {
    "4af52118-c12b-4ad5-30bb-959848357e8a": {
      "match": "brand_token",
      "title": "THAM (TROMETHAMINE) INJECTION, SOLUTION [HOSPIRA, INC.]",
      "spl_version": "21",
      "published_date": "2026-05-28"
    }
  },
  "productid": "0409-1593_66406bf4-d7c7-4e73-9675-defa737c3b75",
  "productndc": "0409-1593",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "013025",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "370MG/VIAL;1.75GM/VIAL;36GM/VIAL",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "18GM/500ML (3.6GM/100ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TROMETHAMINE",
  "proprietary_name": "THAM",
  "active_ingred_unit": "g/100mL",
  "application_number": "NDA013025",
  "marketing_category": "NDA",
  "nonproprietary_name": "TROMETHAMINE",
  "start_marketing_date": "20200624",
  "active_numerator_strength": "3.6"
}

Related drugs

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