ketorolac tromethamine (63323-162)

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 30 mg/mL

Manufacturer

Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-162

Product ID 63323-162_ab476c4c-2c72-47b1-bf42-7a89703b0dd4

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA075784

Listing Expiration 2026-12-31

Marketing Start 2000-10-18

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 63323162

Hyphenated Format 63323-162

Supplemental Identifiers

RxCUI

860092 1665459 1665461

UPC

0363323162115 0363323161002 0363323162009 0363323162030

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

source: ndc

Resolved Composition

Strengths

30 mg/mL

source: ndc

Packaging

25 VIAL, SINGLE-USE in 1 TRAY (63323-162-01) / 1 mL in 1 VIAL, SINGLE-USE (63323-162-00)
25 VIAL, SINGLE-USE in 1 TRAY (63323-162-02) / 2 mL in 1 VIAL, SINGLE-USE (63323-162-03)
25 VIAL in 1 TRAY (63323-162-51) / 1 mL in 1 VIAL (63323-162-11)

source: ndc

Packages (3)

63323-162-01 25 VIAL, SINGLE-USE in 1 TRAY (63323-162-01) / 1 mL in 1 VIAL, SINGLE-USE (63323-162-00) 63323-162-02 25 VIAL, SINGLE-USE in 1 TRAY (63323-162-02) / 2 mL in 1 VIAL, SINGLE-USE (63323-162-03) 63323-162-51 25 VIAL in 1 TRAY (63323-162-51) / 1 mL in 1 VIAL (63323-162-11)

Ingredients (1)

ketorolac tromethamine (30 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"], "spl_id": "ab476c4c-2c72-47b1-bf42-7a89703b0dd4", "openfda": {"upc": ["0363323162115", "0363323161002", "0363323162009", "0363323162030"], "unii": ["4EVE5946BQ"], "rxcui": ["860092", "1665459", "1665461"], "spl_set_id": ["d1920335-8e45-4960-b6e9-e6f1f9e6820c"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-USE in 1 TRAY (63323-162-01)  / 1 mL in 1 VIAL, SINGLE-USE (63323-162-00)", "package_ndc": "63323-162-01", "marketing_start_date": "20001018"}, {"sample": false, "description": "25 VIAL, SINGLE-USE in 1 TRAY (63323-162-02)  / 2 mL in 1 VIAL, SINGLE-USE (63323-162-03)", "package_ndc": "63323-162-02", "marketing_start_date": "20001018"}, {"sample": false, "description": "25 VIAL in 1 TRAY (63323-162-51)  / 1 mL in 1 VIAL (63323-162-11)", "package_ndc": "63323-162-51", "marketing_start_date": "20241001"}], "brand_name": "Ketorolac Tromethamine", "product_id": "63323-162_ab476c4c-2c72-47b1-bf42-7a89703b0dd4", "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": "63323-162", "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": "ANDA075784", "marketing_category": "ANDA", "marketing_start_date": "20001018", "listing_expiration_date": "20261231"}