ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler caplin steriles limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ketorolac tromethamine 5 mg/mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-139
Product ID 65145-139_2fc3da7c-dbd4-4de7-a55f-40d94991e6d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218204
Listing Expiration 2026-12-31
Marketing Start 2025-01-23

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 65145139
Hyphenated Format 65145-139

Supplemental Identifiers

RxCUI
860107
UPC
0365145140012 0365145138019 0365145139016
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 (65145-139-01) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

65145-139-01 1 BOTTLE, DROPPER in 1 CARTON (65145-139-01) / 5 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": "2fc3da7c-dbd4-4de7-a55f-40d94991e6d8", "openfda": {"upc": ["0365145140012", "0365145138019", "0365145139016"], "unii": ["4EVE5946BQ"], "rxcui": ["860107"], "spl_set_id": ["4ba4a228-75d6-4a77-bf34-0381b2a89602"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (65145-139-01)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "65145-139-01", "marketing_start_date": "20250123"}], "brand_name": "Ketorolac Tromethamine", "product_id": "65145-139_2fc3da7c-dbd4-4de7-a55f-40d94991e6d8", "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": "65145-139", "generic_name": "Ketorolac Tromethamine", "labeler_name": "Caplin Steriles Limited", "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": "20250123", "listing_expiration_date": "20261231"}