NDC Compounded Drug 82396-145-25 Lorazepam

Solution, Concentrate Oral

Table of Contents

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

Compounded Drug Product Information

NDC Product Code 82396-145
NDC Package Code 82396-145-25
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.		 82396014525
Package Description .25 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.		 Lorazepam
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.		 Lorazepam
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.		 Lorazepam
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 treat anxiety. Lorazepam belongs to a class of drugs known as benzodiazepines which act on the brain and nerves (central nervous system) to produce a calming effect. This drug works by enhancing the effects of a certain natural chemical in the body (GABA).
Dosage Form Solution, Concentrate - A liquid preparation (i.e., a substance that flows readily in its natural state) that contains a drug dissolved in a suitable solvent or mixture of mutually miscible solvents; the drug has been strengthened by the evaporation of its nonactive parts.
Route Name Oral - Administration to or by way of the mouth.
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 Lorazepam
Active Ingredients Information .25 mg/.125 mL
DEA Schedule What is the Drug Enforcement Administration (DEA) CIV Schedule?
The controlled substances in the CIV schedule have an abuse potential and dependence liability less than those listed in CIII and have an accepted medical use in the United States. 		Schedule IV (CIV) Substances
Reporting Period 2023-2

NDC Crossover Products Matching Lorazepam

NDC crossover of Lorazepam with NDC 82396-145 a human compounded drug with other similar products matching the same substance name (Lorazepam) and the same administration route (oral) or dosage form (solution, concentrate).

Frequently Asked Questions

What is the NDC number assigned to Lorazepam?

Lorazepam was assigned by its manufacturer with NDC product code 82396-145. 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 Lorazepam?

The NDC package code 82396-145-25 was assigned to a .25 mL in 1 SYRINGE, PLASTIC of lorazepam administered oral via solution, concentrate.

Who manufactures this product?

Lorazepam 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 3 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by ANNOVEX PHARMA, INC. and Annovex Pharma, Inc. with NDC product codes 82396-145-05, 82396-145-13 and 82396-145-13.