tromethamine

Generic: tromethamine

Labeler: b. braun medical inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tromethamine
Generic Name tromethamine
Labeler b. braun medical inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tromethamine 3.6 g/100mL

Manufacturer
B. Braun Medical Inc.

Identifiers & Regulatory

Product NDC 0264-8031
Product ID 0264-8031_87d30389-4483-4d62-a623-d4676e7d16c9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211558
Listing Expiration 2026-12-31
Marketing Start 2025-08-27

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02648031
Hyphenated Format 0264-8031

Supplemental Identifiers

RxCUI
198412
UNII
023C2WHX2V

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tromethamine (source: ndc)
Generic Name tromethamine (source: ndc)
Application Number ANDA211558 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 3.6 g/100mL
source: ndc
Packaging
  • 24 BAG in 1 CASE (0264-8031-10) / 500 mL in 1 BAG
source: ndc

Packages (1)

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

Ingredients (1)

tromethamine (3.6 g/100mL)

Linked Drug Pages (1)

TROMETHAMINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "87d30389-4483-4d62-a623-d4676e7d16c9", "openfda": {"unii": ["023C2WHX2V"], "rxcui": ["198412"], "spl_set_id": ["57db5686-7f7f-4999-87e3-e1cbbda4a98d"], "manufacturer_name": ["B. Braun Medical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BAG in 1 CASE (0264-8031-10)  / 500 mL in 1 BAG", "package_ndc": "0264-8031-10", "marketing_start_date": "20250827"}], "brand_name": "TROMETHAMINE", "product_id": "0264-8031_87d30389-4483-4d62-a623-d4676e7d16c9", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "0264-8031", "generic_name": "TROMETHAMINE", "labeler_name": "B. Braun Medical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TROMETHAMINE", "active_ingredients": [{"name": "TROMETHAMINE", "strength": "3.6 g/100mL"}], "application_number": "ANDA211558", "marketing_category": "ANDA", "marketing_start_date": "20250827", "listing_expiration_date": "20261231"}