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 INTRAVENOUS
Active Ingredients

ketorolac tromethamine 30 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 76045-209
Product ID 76045-209_0dab642d-7fcf-4301-8ac9-10e64a040c6b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203242
Listing Expiration 2026-12-31
Marketing Start 2020-09-01

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 76045209
Hyphenated Format 76045-209

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 INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 30 mg/mL
source: ndc
Packaging
  • 24 BLISTER PACK in 1 CARTON (76045-209-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-209-00) / 1 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

76045-209-10 24 BLISTER PACK in 1 CARTON (76045-209-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-209-00) / 1 mL in 1 SYRINGE, GLASS

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", "INTRAVENOUS"], "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 (76045-209-10)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-209-00)  / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "76045-209-10", "marketing_start_date": "20200901"}], "brand_name": "Ketorolac Tromethamine", "product_id": "76045-209_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": "76045-209", "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": "30 mg/mL"}], "application_number": "ANDA203242", "marketing_category": "ANDA", "marketing_start_date": "20200901", "listing_expiration_date": "20261231"}