tromethamine

Generic: tromethamine

Labeler: milla pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tromethamine
Generic Name tromethamine
Labeler milla pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tromethamine 3.6 g/100mL

Manufacturer
MILLA PHARMACEUTICALS INC.

Identifiers & Regulatory

Product NDC 71357-001
Product ID 71357-001_47d8e7ea-786a-263c-e063-6394a90a6a18
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213116
Listing Expiration 2027-12-31
Marketing Start 2024-12-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71357001
Hyphenated Format 71357-001

Supplemental Identifiers

RxCUI
198412
UPC
0371357001065
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 ANDA213116 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 3.6 g/100mL
source: ndc
Packaging
  • 6 BOTTLE, GLASS in 1 CASE (71357-001-01) / 500 mL in 1 BOTTLE, GLASS (71357-001-06)
source: ndc

Packages (1)

71357-001-01 6 BOTTLE, GLASS in 1 CASE (71357-001-01) / 500 mL in 1 BOTTLE, GLASS (71357-001-06)

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": "47d8e7ea-786a-263c-e063-6394a90a6a18", "openfda": {"upc": ["0371357001065"], "unii": ["023C2WHX2V"], "rxcui": ["198412"], "spl_set_id": ["082b1104-502b-47af-95bf-0dbf2422990e"], "manufacturer_name": ["MILLA PHARMACEUTICALS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BOTTLE, GLASS in 1 CASE (71357-001-01)  / 500 mL in 1 BOTTLE, GLASS (71357-001-06)", "package_ndc": "71357-001-01", "marketing_start_date": "20241231"}], "brand_name": "Tromethamine", "product_id": "71357-001_47d8e7ea-786a-263c-e063-6394a90a6a18", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "71357-001", "generic_name": "Tromethamine", "labeler_name": "MILLA PHARMACEUTICALS INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tromethamine", "active_ingredients": [{"name": "TROMETHAMINE", "strength": "3.6 g/100mL"}], "application_number": "ANDA213116", "marketing_category": "ANDA", "marketing_start_date": "20241231", "listing_expiration_date": "20271231"}