ketorolac tromethamine (69315-322)

Drug Facts

Product Profile

Brand Name ketorolac tromethamine

Generic Name ketorolac tromethamine

Labeler leading pharma, llc

Dosage Form SOLUTION/ DROPS

Routes

OPHTHALMIC

Active Ingredients

ketorolac tromethamine 5 mg/mL

Manufacturer

Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-322

Product ID 69315-322_11be552b-2427-4cd7-a81d-f0ae5063d3f6

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA218204

Listing Expiration 2026-12-31

Marketing Start 2024-06-01

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 69315322

Hyphenated Format 69315-322

Supplemental Identifiers

RxCUI

860107

UPC

0369315322109 0369315322031 0369315322055

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 ANDA218204 (source: ndc)

Routes

OPHTHALMIC

source: ndc

Resolved Composition

Strengths

5 mg/mL

source: ndc

Packaging

1 BOTTLE, DROPPER in 1 CARTON (69315-322-03) / 3 mL in 1 BOTTLE, DROPPER
1 BOTTLE, DROPPER in 1 CARTON (69315-322-05) / 5 mL in 1 BOTTLE, DROPPER
1 BOTTLE, DROPPER in 1 CARTON (69315-322-10) / 10 mL in 1 BOTTLE, DROPPER

source: ndc

Packages (3)

69315-322-03 1 BOTTLE, DROPPER in 1 CARTON (69315-322-03) / 3 mL in 1 BOTTLE, DROPPER 69315-322-05 1 BOTTLE, DROPPER in 1 CARTON (69315-322-05) / 5 mL in 1 BOTTLE, DROPPER 69315-322-10 1 BOTTLE, DROPPER in 1 CARTON (69315-322-10) / 10 mL in 1 BOTTLE, DROPPER

Ingredients (1)

ketorolac tromethamine (5 mg/mL)

Linked Drug Pages (1)

Ketorolac Tromethamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["OPHTHALMIC"], "spl_id": "11be552b-2427-4cd7-a81d-f0ae5063d3f6", "openfda": {"upc": ["0369315322109", "0369315322031", "0369315322055"], "unii": ["4EVE5946BQ"], "rxcui": ["860107"], "spl_set_id": ["c34b69c6-5cdf-41f6-8652-33bd8e9c6c70"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (69315-322-03)  / 3 mL in 1 BOTTLE, DROPPER", "package_ndc": "69315-322-03", "marketing_start_date": "20240601"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (69315-322-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "69315-322-05", "marketing_start_date": "20240601"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (69315-322-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "69315-322-10", "marketing_start_date": "20240601"}], "brand_name": "Ketorolac Tromethamine", "product_id": "69315-322_11be552b-2427-4cd7-a81d-f0ae5063d3f6", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69315-322", "generic_name": "Ketorolac Tromethamine", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac Tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "5 mg/mL"}], "application_number": "ANDA218204", "marketing_category": "ANDA", "marketing_start_date": "20240601", "listing_expiration_date": "20261231"}