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 15 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-161
Product ID 63323-161_55ed7afb-db66-4b28-939b-db45b55bf058
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075784
Listing Expiration 2026-12-31
Marketing Start 2001-09-05

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 63323161
Hyphenated Format 63323-161

Supplemental Identifiers

RxCUI
860092 1665459 1665461
UPC
0363323161217 0363323162238 0363323162252
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 ANDA075784 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 15 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-161-12) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-161-21)
source: ndc

Packages (1)

63323-161-12 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-161-12) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-161-21)

Ingredients (1)

ketorolac tromethamine (15 mg/mL)

Linked Drug Pages (3)

Ketorolac Tromethamine ndc-match (0.9) Ketorolac Tromethamine ndc-match (0.9) Ketorolac Tromethamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "55ed7afb-db66-4b28-939b-db45b55bf058", "openfda": {"upc": ["0363323161217", "0363323162238", "0363323162252"], "unii": ["4EVE5946BQ"], "rxcui": ["860092", "1665459", "1665461"], "spl_set_id": ["950b7295-3f68-4027-ac2b-2f7d0f5f8ef9"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-161-12)  / 1 mL in 1 VIAL, SINGLE-DOSE (63323-161-21)", "package_ndc": "63323-161-12", "marketing_start_date": "20010905"}], "brand_name": "Ketorolac Tromethamine", "product_id": "63323-161_55ed7afb-db66-4b28-939b-db45b55bf058", "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": "63323-161", "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": "15 mg/mL"}], "application_number": "ANDA075784", "marketing_category": "ANDA", "marketing_start_date": "20010905", "listing_expiration_date": "20261231"}