ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ketorolac tromethamine 10 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4161
Product ID 70518-4161_4690962c-8f26-b9fc-e063-6394a90a0213
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216759
Listing Expiration 2026-12-31
Marketing Start 2024-08-15

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 705184161
Hyphenated Format 70518-4161

Supplemental Identifiers

RxCUI
834022
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 ANDA216759 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4161-1)
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4161-2)
  • 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4161-3)
source: ndc

Packages (3)

70518-4161-1 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4161-1) 70518-4161-2 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4161-2) 70518-4161-3 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4161-3)

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": "4690962c-8f26-b9fc-e063-6394a90a0213", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["834022"], "spl_set_id": ["04d5114e-332b-4ed0-85df-b276c1dc296c"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4161-1)", "package_ndc": "70518-4161-1", "marketing_start_date": "20240913"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4161-2)", "package_ndc": "70518-4161-2", "marketing_start_date": "20240926"}, {"sample": false, "description": "12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4161-3)", "package_ndc": "70518-4161-3", "marketing_start_date": "20251222"}], "brand_name": "Ketorolac Tromethamine", "product_id": "70518-4161_4690962c-8f26-b9fc-e063-6394a90a0213", "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": "70518-4161", "generic_name": "Ketorolac Tromethamine", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac Tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "10 mg/1"}], "application_number": "ANDA216759", "marketing_category": "ANDA", "marketing_start_date": "20240815", "listing_expiration_date": "20261231"}