ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

ketorolac tromethamine 60 mg/2mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 76045-105
Product ID 76045-105_0dab642d-7fcf-4301-8ac9-10e64a040c6b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203242
Listing Expiration 2026-12-31
Marketing Start 2015-11-02

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 76045105
Hyphenated Format 76045-105

Supplemental Identifiers

RxCUI
860113 860114 860115
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 ANDA203242 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 60 mg/2mL
source: ndc
Packaging
  • 24 BLISTER PACK in 1 CARTON (76045-105-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 2 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

76045-105-20 24 BLISTER PACK in 1 CARTON (76045-105-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 2 mL in 1 SYRINGE, GLASS

Ingredients (1)

ketorolac tromethamine (60 mg/2mL)

Linked Drug Pages (1)

Ketorolac Tromethamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "0dab642d-7fcf-4301-8ac9-10e64a040c6b", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["860113", "860114", "860115"], "spl_set_id": ["3d88cbe6-5230-47aa-80af-0c41283d1f00"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BLISTER PACK in 1 CARTON (76045-105-20)  / 1 SYRINGE, GLASS in 1 BLISTER PACK / 2 mL in 1 SYRINGE, GLASS", "package_ndc": "76045-105-20", "marketing_start_date": "20151102"}], "brand_name": "Ketorolac Tromethamine", "product_id": "76045-105_0dab642d-7fcf-4301-8ac9-10e64a040c6b", "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": "76045-105", "generic_name": "Ketorolac Tromethamine", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac Tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "60 mg/2mL"}], "application_number": "ANDA203242", "marketing_category": "ANDA", "marketing_start_date": "20151102", "listing_expiration_date": "20261231"}