ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler a-s medication solutions
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ketorolac tromethamine 4 mg/mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-3550
Product ID 50090-3550_a63c6172-9e50-4b41-9771-3203a41df0dc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021528
Listing Expiration 2026-12-31
Marketing Start 2013-11-21

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 500903550
Hyphenated Format 50090-3550

Supplemental Identifiers

RxCUI
860103
UNII
4EVE5946BQ

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 NDA021528 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 4 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (50090-3550-0) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

50090-3550-0 1 BOTTLE, DROPPER in 1 CARTON (50090-3550-0) / 5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

ketorolac tromethamine (4 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": "a63c6172-9e50-4b41-9771-3203a41df0dc", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["860103"], "spl_set_id": ["1580b751-15ff-4193-8f22-25a9a468989a"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (50090-3550-0)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "50090-3550-0", "marketing_start_date": "20180823"}], "brand_name": "KETOROLAC TROMETHAMINE", "product_id": "50090-3550_a63c6172-9e50-4b41-9771-3203a41df0dc", "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": "50090-3550", "generic_name": "Ketorolac Tromethamine", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KETOROLAC TROMETHAMINE", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "4 mg/mL"}], "application_number": "NDA021528", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20131121", "listing_expiration_date": "20261231"}