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/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ketorolac tromethamine 5 mg/mL

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-777
Product ID 63187-777_df37d0b1-1981-4c46-a3a6-60712c06370c
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 63187777
Hyphenated Format 63187-777

Supplemental Identifiers

RxCUI
860107
UPC
0363187777050
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 ANDA076109 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (63187-777-05) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (63187-777-10) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

63187-777-05 1 BOTTLE, DROPPER in 1 CARTON (63187-777-05) / 5 mL in 1 BOTTLE, DROPPER 63187-777-10 1 BOTTLE, DROPPER in 1 CARTON (63187-777-10) / 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": "df37d0b1-1981-4c46-a3a6-60712c06370c", "openfda": {"upc": ["0363187777050"], "unii": ["4EVE5946BQ"], "rxcui": ["860107"], "spl_set_id": ["2f27e304-7a96-47b6-8ef1-8a649c25abcf"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (63187-777-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "63187-777-05", "marketing_start_date": "20161101"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (63187-777-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "63187-777-10", "marketing_start_date": "20161101"}], "brand_name": "Ketorolac Tromethamine", "product_id": "63187-777_df37d0b1-1981-4c46-a3a6-60712c06370c", "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": "63187-777", "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": "ANDA076109", "marketing_category": "ANDA", "marketing_start_date": "20091207", "listing_expiration_date": "20261231"}