🇺🇸
United States · US · US:71357-001_47d8e7ea-786a-263c-e063-6394a90a6a18
Tromethamine
Orange BookUNIISPLATC B05BB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMILLA PHARMACEUTICALS INC.
CountryUS (United States)
ATC codeB05BB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171357001016 BOTTLE, GLASS in 1 CASE (71357-001-01) / 500 mL in 1 BOTTLE, GLASS (71357-001-06)
Annotations
UNII (FDA Substance ID)
023C2WHX2V
TROMETHAMINE
RxCUI 10865
Orange Book
A213116
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": "71357-001_47d8e7ea-786a-263c-e063-6394a90a6a18",
"productndc": "71357-001",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "213116",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "18GM/500ML (3.6GM/100ML)",
"product_no": "001",
"approval_date": "Dec 31, 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": "ANDA213116",
"marketing_category": "ANDA",
"nonproprietary_name": "Tromethamine",
"start_marketing_date": "20241231",
"active_numerator_strength": "3.6"
}Related drugs
Other records sharing ATC code B05BB03.
- 🇺🇸THAMHospira, Inc.
- NOTribonatFresenius Kabi Norge AS
- GBTris 36.34% solution for infusion 20ml ampoulesImported (Germany)
- GBTrometamol 3.6% solution for infusion 100ml bottlesSpecial Order
- GBTrometamol 3.6% solution for infusion 10ml ampoulesSpecial Order
- GBTrometamol 3.6% solution for infusion 500ml bottlesSpecial Order
- GBTrometamol 3.6% solution for infusion 5ml ampoulesSpecial Order
- GBTrometamol 4.03% infusion 100ml bagsSpecial Order
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