ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

ketorolac tromethamine 60 mg/2mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-341
Product ID 55150-341_74f71a7a-b89a-4ad2-a19d-4f2fb87b040f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212939
Listing Expiration 2026-12-31
Marketing Start 2020-10-20

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitor [epc] cyclooxygenase inhibitors [moa] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150341
Hyphenated Format 55150-341

Supplemental Identifiers

RxCUI
860092 1665459 1665461
UPC
0355150340019 0355150341016 0355150339013
UNII
4EVE5946BQ

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 ketorolac tromethamine (source: ndc)
Generic Name ketorolac tromethamine (source: ndc)
Application Number ANDA212939 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 60 mg/2mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-341-01) / 2 mL in 1 VIAL, SINGLE-DOSE
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-341-25) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

55150-341-01 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-341-01) / 2 mL in 1 VIAL, SINGLE-DOSE 55150-341-25 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-341-25) / 2 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

ketorolac tromethamine (60 mg/2mL)

Linked Drug Pages (1)

KETOROLAC TROMETHAMINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "74f71a7a-b89a-4ad2-a19d-4f2fb87b040f", "openfda": {"upc": ["0355150340019", "0355150341016", "0355150339013"], "unii": ["4EVE5946BQ"], "rxcui": ["860092", "1665459", "1665461"], "spl_set_id": ["f520978f-9046-4ff8-b04d-0f615fdeae4d"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55150-341-01)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-341-01", "marketing_start_date": "20201020"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (55150-341-25)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-341-25", "marketing_start_date": "20201020"}], "brand_name": "KETOROLAC TROMETHAMINE", "product_id": "55150-341_74f71a7a-b89a-4ad2-a19d-4f2fb87b040f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "55150-341", "generic_name": "KETOROLAC TROMETHAMINE", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KETOROLAC TROMETHAMINE", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "60 mg/2mL"}], "application_number": "ANDA212939", "marketing_category": "ANDA", "marketing_start_date": "20201020", "listing_expiration_date": "20261231"}