NDC Compounded Drug 82396-141-05 Labetalol Hydrochloride

Injection, Solution Intravenous

Table of Contents

    1. Compounded Product Information
    2. NDC Crossover Products Matching Labetalol Hydrochloride
    3. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 82396-141
NDC Package Code 82396-141-05
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.		 82396014105
Package Description 5 mL in 1 SYRINGE, PLASTIC
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.		 Labetalol Hydrochloride
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.		 Labetalol Hydrochloride
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.		 Labetalol Hydrochloride
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 Intravenous - Administration within or into a vein or veins.
Marketing Category OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Code 82396
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Annovex Pharma, Inc.
Substance Name Labetalol Hydrochloride
Active Ingredients Information 5 mg/1 mL
Reporting Period 2024-2

NDC Crossover Products Matching Labetalol Hydrochloride

NDC crossover of Labetalol Hydrochloride with NDC 82396-141 a human compounded drug with other similar products matching the same substance name (Labetalol Hydrochloride) and the same administration route (intravenous) or dosage form (injection, solution).

Frequently Asked Questions

What is the NDC number assigned to Labetalol Hydrochloride 5mg/ml?

Labetalol Hydrochloride 5mg/ml was assigned by its manufacturer with NDC product code 82396-141. 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 Labetalol Hydrochloride 5mg/ml?

The NDC package code 82396-141-05 was assigned to a 5 mL in 1 SYRINGE, PLASTIC of labetalol hydrochloride administered intravenous via injection, solution.

Who manufactures this product?

Labetalol Hydrochloride 5mg/ml is manufactured by an outsourced facility and labeled by Annovex Pharma, 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.

Which are the NDC crossover matchings for this product?

We found 2 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by Nephron Sterile Compounding Center, LLC with NDC product codes 69374-946-34 and 69374-946-34.