ketorolac tromethamine (55150-339)

Drug Facts

Product Profile

Brand Name ketorolac tromethamine

Generic Name ketorolac tromethamine

Labeler eugia us llc

Dosage Form INJECTION, SOLUTION

Routes

INTRAMUSCULAR INTRAVENOUS

Active Ingredients

ketorolac tromethamine 15 mg/mL

Manufacturer

Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-339

Product ID 55150-339_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 55150339

Hyphenated Format 55150-339

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 INTRAVENOUS

source: ndc

Resolved Composition

Strengths

15 mg/mL

source: ndc

Packaging

1 VIAL, SINGLE-DOSE in 1 CARTON (55150-339-01) / 1 mL in 1 VIAL, SINGLE-DOSE
25 VIAL, SINGLE-DOSE in 1 CARTON (55150-339-25) / 1 mL in 1 VIAL, SINGLE-DOSE

source: ndc

Packages (2)

55150-339-01 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-339-01) / 1 mL in 1 VIAL, SINGLE-DOSE 55150-339-25 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-339-25) / 1 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

ketorolac tromethamine (15 mg/mL)

Linked Drug Pages (1)

KETOROLAC TROMETHAMINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "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 (55150-339-01)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-339-01", "marketing_start_date": "20201020"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (55150-339-25)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-339-25", "marketing_start_date": "20201020"}], "brand_name": "KETOROLAC TROMETHAMINE", "product_id": "55150-339_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": "55150-339", "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": "15 mg/mL"}], "application_number": "ANDA212939", "marketing_category": "ANDA", "marketing_start_date": "20201020", "listing_expiration_date": "20261231"}