ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: civica, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler civica, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ketorolac tromethamine 15 mg/mL

Manufacturer
Civica, Inc.

Identifiers & Regulatory

Product NDC 72572-354
Product ID 72572-354_36757566-9551-4adc-8783-3f5054c370e8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209900
Listing Expiration 2026-12-31
Marketing Start 2023-03-25

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 72572354
Hyphenated Format 72572-354

Supplemental Identifiers

RxCUI
860092 1665461
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 ANDA209900 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 15 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (72572-354-10) / 1 mL in 1 VIAL, SINGLE-DOSE (72572-354-01)
source: ndc

Packages (1)

72572-354-10 10 VIAL, SINGLE-DOSE in 1 CARTON (72572-354-10) / 1 mL in 1 VIAL, SINGLE-DOSE (72572-354-01)

Ingredients (1)

ketorolac tromethamine (15 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": "36757566-9551-4adc-8783-3f5054c370e8", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["860092", "1665461"], "spl_set_id": ["1e8ddf13-c513-4e16-a91a-9d55726d9071"], "manufacturer_name": ["Civica, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (72572-354-10)  / 1 mL in 1 VIAL, SINGLE-DOSE (72572-354-01)", "package_ndc": "72572-354-10", "marketing_start_date": "20230325"}], "brand_name": "Ketorolac Tromethamine", "product_id": "72572-354_36757566-9551-4adc-8783-3f5054c370e8", "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": "72572-354", "generic_name": "KETOROLAC TROMETHAMINE", "labeler_name": "Civica, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac Tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "15 mg/mL"}], "application_number": "ANDA209900", "marketing_category": "ANDA", "marketing_start_date": "20230325", "listing_expiration_date": "20261231"}