ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ketorolac tromethamine 10 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-032
Product ID 76420-032_04ab174a-3ae9-2b8e-e063-6394a90a1df5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074754
Listing Expiration 2026-12-31
Marketing Start 1998-06-17

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 76420032
Hyphenated Format 76420-032

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 ANDA074754 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (76420-032-01)
  • 2 TABLET, FILM COATED in 1 BOTTLE (76420-032-02)
  • 4 TABLET, FILM COATED in 1 BOTTLE (76420-032-04)
  • 7 TABLET, FILM COATED in 1 BOTTLE (76420-032-07)
  • 10 TABLET, FILM COATED in 1 BOTTLE (76420-032-10)
  • 15 TABLET, FILM COATED in 1 BOTTLE (76420-032-15)
  • 20 TABLET, FILM COATED in 1 BOTTLE (76420-032-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE (76420-032-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (76420-032-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76420-032-90)
source: ndc

Packages (10)

76420-032-01 100 TABLET, FILM COATED in 1 BOTTLE (76420-032-01) 76420-032-02 2 TABLET, FILM COATED in 1 BOTTLE (76420-032-02) 76420-032-04 4 TABLET, FILM COATED in 1 BOTTLE (76420-032-04) 76420-032-07 7 TABLET, FILM COATED in 1 BOTTLE (76420-032-07) 76420-032-10 10 TABLET, FILM COATED in 1 BOTTLE (76420-032-10) 76420-032-15 15 TABLET, FILM COATED in 1 BOTTLE (76420-032-15) 76420-032-20 20 TABLET, FILM COATED in 1 BOTTLE (76420-032-20) 76420-032-30 30 TABLET, FILM COATED in 1 BOTTLE (76420-032-30) 76420-032-60 60 TABLET, FILM COATED in 1 BOTTLE (76420-032-60) 76420-032-90 90 TABLET, FILM COATED in 1 BOTTLE (76420-032-90)

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": "04ab174a-3ae9-2b8e-e063-6394a90a1df5", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["834022"], "spl_set_id": ["94c7c57a-fd1e-41ab-bc39-9a538f6011d1"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (76420-032-01)", "package_ndc": "76420-032-01", "marketing_start_date": "20220916"}, {"sample": false, "description": "2 TABLET, FILM COATED in 1 BOTTLE (76420-032-02)", "package_ndc": "76420-032-02", "marketing_start_date": "20201110"}, {"sample": false, "description": "4 TABLET, FILM COATED in 1 BOTTLE (76420-032-04)", "package_ndc": "76420-032-04", "marketing_start_date": "20201110"}, {"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE (76420-032-07)", "package_ndc": "76420-032-07", "marketing_start_date": "20230906"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (76420-032-10)", "package_ndc": "76420-032-10", "marketing_start_date": "20220916"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (76420-032-15)", "package_ndc": "76420-032-15", "marketing_start_date": "20220916"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (76420-032-20)", "package_ndc": "76420-032-20", "marketing_start_date": "20220916"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76420-032-30)", "package_ndc": "76420-032-30", "marketing_start_date": "20220916"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (76420-032-60)", "package_ndc": "76420-032-60", "marketing_start_date": "20220916"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76420-032-90)", "package_ndc": "76420-032-90", "marketing_start_date": "20220916"}], "brand_name": "Ketorolac Tromethamine", "product_id": "76420-032_04ab174a-3ae9-2b8e-e063-6394a90a1df5", "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": "76420-032", "generic_name": "Ketorolac Tromethamine", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac Tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "10 mg/1"}], "application_number": "ANDA074754", "marketing_category": "ANDA", "marketing_start_date": "19980617", "listing_expiration_date": "20261231"}