ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: sportpharm llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler sportpharm llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

ketorolac tromethamine 30 mg/mL

Manufacturer
Sportpharm LLC

Identifiers & Regulatory

Product NDC 85766-017
Product ID 85766-017_49eee362-9352-643e-e063-6394a90a994f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204216
Listing Expiration 2027-12-31
Marketing Start 2023-06-23

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 85766017
Hyphenated Format 85766-017

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
  • HOW SUPPLIED Ketorolac Tromethamine Injection, USP is supplied as follows: 60 mg/2 mL, 2 mL single-dose vial NDC 85766-017-02 (relabeled from NDC 72266-119-01*) *FOR IM USE ONLY Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature . ] Protect from light . Retain in carton until time of use. Distributed by: Sportpharm LLC 379 Van Ness Ave 1401, Torrance, CA 90501 Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL label
source: label

Packages (0)

No package records.

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": "49eee362-9352-643e-e063-6394a90a994f", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["1665459"], "spl_set_id": ["2a23b0fa-803c-4abb-b588-12cfe83326a9"], "manufacturer_name": ["Sportpharm LLC"]}, "finished": true, "packaging": [], "brand_name": "ketorolac tromethamine", "product_id": "85766-017_49eee362-9352-643e-e063-6394a90a994f", "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": "85766-017", "generic_name": "ketorolac tromethamine", "labeler_name": "Sportpharm LLC", "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": "20230623", "listing_expiration_date": "20271231"}