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 5 mg/mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-770
Product ID 65862-770_1c79d44d-8f10-4a8f-a0b5-21c2ba258777
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205190
Listing Expiration 2026-12-31
Marketing Start 2020-12-03

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 65862770
Hyphenated Format 65862-770

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 ANDA205190 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (65862-770-05) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

65862-770-05 1 BOTTLE in 1 CARTON (65862-770-05) / 5 mL in 1 BOTTLE

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": "1c79d44d-8f10-4a8f-a0b5-21c2ba258777", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["860107"], "spl_set_id": ["007a4da5-d794-416c-94b3-6ee9e7842c52"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65862-770-05)  / 5 mL in 1 BOTTLE", "package_ndc": "65862-770-05", "marketing_start_date": "20201203"}], "brand_name": "Ketorolac Tromethamine", "product_id": "65862-770_1c79d44d-8f10-4a8f-a0b5-21c2ba258777", "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": "65862-770", "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": "5 mg/mL"}], "application_number": "ANDA205190", "marketing_category": "ANDA", "marketing_start_date": "20201203", "listing_expiration_date": "20261231"}