ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler proficient rx lp
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

ketorolac tromethamine 5 mg/mL

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-628
Product ID 63187-628_ff9f9a3f-028e-49bd-8283-ad948d93a27f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078434
Listing Expiration 2026-12-31
Marketing Start 2009-11-05

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 63187628
Hyphenated Format 63187-628

Supplemental Identifiers

RxCUI
860107
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 ANDA078434 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (63187-628-05) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

63187-628-05 1 BOTTLE, DROPPER in 1 CARTON (63187-628-05) / 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": "ff9f9a3f-028e-49bd-8283-ad948d93a27f", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["860107"], "spl_set_id": ["fc8ba956-4d3d-4f52-ac8e-89d52a480b48"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (63187-628-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "63187-628-05", "marketing_start_date": "20181201"}], "brand_name": "Ketorolac Tromethamine", "product_id": "63187-628_ff9f9a3f-028e-49bd-8283-ad948d93a27f", "dosage_form": "SOLUTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "63187-628", "generic_name": "ketorolac tromethamine", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac Tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "5 mg/mL"}], "application_number": "ANDA078434", "marketing_category": "ANDA", "marketing_start_date": "20091105", "listing_expiration_date": "20261231"}