ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler direct_rx
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

ketorolac tromethamine 30 mg/mL

Manufacturer
Direct_rx

Identifiers & Regulatory

Product NDC 72189-583
Product ID 72189-583_22de8e1c-5e69-fd78-e063-6394a90ad40b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204216
Listing Expiration 2026-12-31
Marketing Start 2024-09-24

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 72189583
Hyphenated Format 72189-583

Supplemental Identifiers

RxCUI
1665459
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 ANDA204216 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 30 mg/mL
source: ndc
Packaging
  • 1 mL in 1 CARTON (72189-583-01)
source: ndc

Packages (1)

72189-583-01 1 mL in 1 CARTON (72189-583-01)

Ingredients (1)

ketorolac tromethamine (30 mg/mL)

Linked Drug Pages (1)

Ketorolac Tromethamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "22de8e1c-5e69-fd78-e063-6394a90ad40b", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["1665459"], "spl_set_id": ["22de8e1c-5e68-fd78-e063-6394a90ad40b"], "manufacturer_name": ["Direct_rx"]}, "finished": true, "packaging": [{"sample": false, "description": "1 mL in 1 CARTON (72189-583-01)", "package_ndc": "72189-583-01", "marketing_start_date": "20240924"}], "brand_name": "Ketorolac Tromethamine", "product_id": "72189-583_22de8e1c-5e69-fd78-e063-6394a90ad40b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "72189-583", "generic_name": "Ketorolac Tromethamine", "labeler_name": "Direct_rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac Tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "30 mg/mL"}], "application_number": "ANDA204216", "marketing_category": "ANDA", "marketing_start_date": "20240924", "listing_expiration_date": "20261231"}