ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ketorolac tromethamine 10 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7303
Product ID 0904-7303_c3e25550-bc2b-4c8f-96bb-61c3e2e28608
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215788
Marketing Start 2024-08-30
Marketing End 2026-11-30

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 09047303
Hyphenated Format 0904-7303

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 ANDA215788 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0904-7303-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7303-04 30 BLISTER PACK in 1 CARTON (0904-7303-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "c3e25550-bc2b-4c8f-96bb-61c3e2e28608", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["834022"], "spl_set_id": ["48245718-a2df-4938-8d06-3b8abf34181e"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-7303-04)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-7303-04", "marketing_end_date": "20261130", "marketing_start_date": "20240830"}], "brand_name": "Ketorolac Tromethamine", "product_id": "0904-7303_c3e25550-bc2b-4c8f-96bb-61c3e2e28608", "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": "0904-7303", "generic_name": "ketorolac tromethamine", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac Tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "10 mg/1"}], "application_number": "ANDA215788", "marketing_category": "ANDA", "marketing_end_date": "20261130", "marketing_start_date": "20240830"}