ketorolac tromethamine

Generic: ketorolac tromethamine

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

Drug Facts

Product Profile

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

ketorolac tromethamine 30 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9997
Product ID 0404-9997_780f22cb-ab18-448a-862c-8d28b9329213
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204216
Listing Expiration 2026-12-31
Marketing Start 2023-08-25

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 04049997
Hyphenated Format 0404-9997

Supplemental Identifiers

RxCUI
1665459
UNII
4EVE5946BQ

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 ANDA204216 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 30 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 BAG (0404-9997-02) / 2 mL in 1 VIAL
source: ndc

Packages (1)

0404-9997-02 1 VIAL in 1 BAG (0404-9997-02) / 2 mL in 1 VIAL

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"], "spl_id": "780f22cb-ab18-448a-862c-8d28b9329213", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["1665459"], "spl_set_id": ["606b0f2f-de28-42a9-96f4-cacba2c7c56a"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BAG (0404-9997-02)  / 2 mL in 1 VIAL", "package_ndc": "0404-9997-02", "marketing_start_date": "20230825"}], "brand_name": "Ketorolac tromethamine", "product_id": "0404-9997_780f22cb-ab18-448a-862c-8d28b9329213", "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": "0404-9997", "generic_name": "Ketorolac tromethamine", "labeler_name": "Henry Schein, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "30 mg/mL"}], "application_number": "ANDA204216", "marketing_category": "ANDA", "marketing_start_date": "20230825", "listing_expiration_date": "20261231"}