ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler leading pharma, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ketorolac tromethamine 10 mg/1

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-260
Product ID 69315-260_aedd35df-9c0a-4dfb-ac09-dcb63675a420
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215745
Listing Expiration 2026-12-31
Marketing Start 2024-03-01

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 69315260
Hyphenated Format 69315-260

Supplemental Identifiers

RxCUI
834022
UPC
0369315260012
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 ANDA215745 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (69315-260-01)
source: ndc

Packages (1)

69315-260-01 100 TABLET, FILM COATED in 1 BOTTLE (69315-260-01)

Ingredients (1)

ketorolac tromethamine (10 mg/1)

Linked Drug Pages (1)

KETOROLAC TROMETHAMINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "aedd35df-9c0a-4dfb-ac09-dcb63675a420", "openfda": {"upc": ["0369315260012"], "unii": ["4EVE5946BQ"], "rxcui": ["834022"], "spl_set_id": ["04df9620-6dcb-494a-83e2-6d28036be974"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (69315-260-01)", "package_ndc": "69315-260-01", "marketing_start_date": "20240301"}], "brand_name": "KETOROLAC TROMETHAMINE", "product_id": "69315-260_aedd35df-9c0a-4dfb-ac09-dcb63675a420", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69315-260", "generic_name": "KETOROLAC TROMETHAMINE", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KETOROLAC TROMETHAMINE", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "10 mg/1"}], "application_number": "ANDA215745", "marketing_category": "ANDA", "marketing_start_date": "20240301", "listing_expiration_date": "20261231"}