ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler apotex corp.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ketorolac tromethamine 5 mg/mL

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-1003
Product ID 60505-1003_fb740a51-5459-3c22-949d-7e4c9142fe84
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076109
Listing Expiration 2026-12-31
Marketing Start 2009-12-07

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 605051003
Hyphenated Format 60505-1003

Supplemental Identifiers

RxCUI
860107
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 ANDA076109 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (60505-1003-1) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (60505-1003-2) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

60505-1003-1 1 BOTTLE, DROPPER in 1 CARTON (60505-1003-1) / 5 mL in 1 BOTTLE, DROPPER 60505-1003-2 1 BOTTLE, DROPPER in 1 CARTON (60505-1003-2) / 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": "fb740a51-5459-3c22-949d-7e4c9142fe84", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["860107"], "spl_set_id": ["d9a186ba-74a9-b6d4-1109-1e045ba1763e"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60505-1003-1)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "60505-1003-1", "marketing_start_date": "20091207"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60505-1003-2)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "60505-1003-2", "marketing_start_date": "20091207"}], "brand_name": "Ketorolac Tromethamine", "product_id": "60505-1003_fb740a51-5459-3c22-949d-7e4c9142fe84", "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": "60505-1003", "generic_name": "ketorolac tromethamine", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac Tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "5 mg/mL"}], "application_number": "ANDA076109", "marketing_category": "ANDA", "marketing_start_date": "20091207", "listing_expiration_date": "20261231"}