NDC Compounded Drug 69852-123-10 Ketorolac Tromethamine

Injection, Solution Intramuscular

Table of Contents

    1. Compounded Product Information
    2. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 69852-123
NDC Package Code 69852-123-10
11-Digit NDC Billing Format NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.		 69852012310
Package Description 300 mg in 1 VIAL, MULTI-DOSE
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		 Human Compounded Drug
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		 Ketorolac Tromethamine 30 Mg/ml
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		 Ketorolac Tromethamine 30 Mg/ml
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		 Ketorolac Tromethamine
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.		 This medication is used to temporarily relieve itching eyes caused by seasonal allergies. It is also used to prevent and treat eye swelling due to a certain type of eye surgery (cataract removal). Ketorolac belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). It works by blocking certain natural substances in your body to reduce pain and swelling.
Dosage Form Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Route Name Intramuscular - Administration within a muscle.
Marketing Category OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Code 69852
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Eagle Pharmacy, Inc.
Substance Name Ketorolac Tromethamine
Active Ingredients Information 30 mg/30 mg
Reporting Period 2021-2

Frequently Asked Questions

What is the NDC number assigned to Ketorolac Tromethamine 30 Mg/ml?

Ketorolac Tromethamine 30 Mg/ml was assigned by its manufacturer with NDC product code 69852-123. This product is a drug classified as a human compounded drug. Compounded drugs are medications created by combining or altering existing drugs to meet the specific needs of certain patients. The NDC directory only includes information about compounded drugs from facilities that choose to assign NDC numbers to their products.

Which are the NDC package codes for Ketorolac Tromethamine 30 Mg/ml?

The NDC package code 69852-123-10 was assigned to a 300 mg in 1 VIAL, MULTI-DOSE of ketorolac tromethamine administered intramuscular via injection, solution.

Who manufactures this product?

Ketorolac Tromethamine 30 Mg/ml is manufactured by an outsourced facility and labeled by Eagle Pharmacy, Inc.. All compounded drugs included in the NDC directory are classified as "Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements)". Outsourcing facilities are a type of drug compounding facility regulated under Section 503B of the FD&C Act could be eligible for exemptions from drug registration if they meet all the conditions specified under Section 503B.