ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ketorolac tromethamine 4 mg/mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-775
Product ID 65862-775_ffe3b63b-abfc-455b-bc6c-49cd58e406e0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205191
Listing Expiration 2026-12-31
Marketing Start 2018-11-15

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 65862775
Hyphenated Format 65862-775

Supplemental Identifiers

RxCUI
860103
UPC
0365862775054
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 ANDA205191 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 4 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (65862-775-05) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

65862-775-05 1 BOTTLE in 1 CARTON (65862-775-05) / 5 mL in 1 BOTTLE

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": "ffe3b63b-abfc-455b-bc6c-49cd58e406e0", "openfda": {"upc": ["0365862775054"], "unii": ["4EVE5946BQ"], "rxcui": ["860103"], "spl_set_id": ["e93f6501-827d-474c-b660-765b7c0fb871"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65862-775-05)  / 5 mL in 1 BOTTLE", "package_ndc": "65862-775-05", "marketing_start_date": "20181115"}], "brand_name": "Ketorolac Tromethamine", "product_id": "65862-775_ffe3b63b-abfc-455b-bc6c-49cd58e406e0", "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": "65862-775", "generic_name": "Ketorolac Tromethamine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac Tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "4 mg/mL"}], "application_number": "ANDA205191", "marketing_category": "ANDA", "marketing_start_date": "20181115", "listing_expiration_date": "20261231"}