NDC Compounded Drug 61141-1337-1 Midazolam

Injection, Solution Intravenous

Table of Contents

    1. Compounded Product Information
    2. NDC Crossover Products Matching Midazolam Hcl 50mg/50ml (1mg/ml) Bag
    3. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 61141-1337
NDC Package Code 61141-1337-1
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.		 61141133701
Package Description 50 mL in 1 BAG
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.		 Midazolam Hcl 50mg/50ml (1mg/ml) Bag
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.		 Midazolam Hcl
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.		 Midazolam
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.		 Midazolam is used before surgery or a procedure. It helps to cause drowsiness, decrease anxiety, and to decrease your memory of the surgery or procedure. This medication may also be used to help with anesthesia or to sedate people who need a tube or machine to help with breathing. Midazolam works by calming the brain and nerves. It belongs to a class of drugs known as benzodiazepines.
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 61141
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Medi-fare Drug
Substance Name Midazolam
Active Ingredients Information 1 mg/1 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 2021-2

NDC Crossover Products Matching Midazolam

NDC crossover of Midazolam Hcl 50mg/50ml (1mg/ml) Bag with NDC 61141-1337 a human compounded drug with other similar products matching the same substance name (Midazolam) and the same administration route (intravenous) or dosage form (injection, solution).

Frequently Asked Questions

What is the NDC number assigned to Midazolam Hcl?

Midazolam Hcl was assigned by its manufacturer with NDC product code 61141-1337. 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 Midazolam Hcl?

The NDC package code 61141-1337-1 was assigned to a 50 mL in 1 BAG of midazolam administered intravenous via injection, solution.

Who manufactures this product?

Midazolam Hcl is manufactured by an outsourced facility and labeled by Medi-fare Drug. 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 7 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by Nephron Sterile Compounding Center, LLC, SterRx LLC, Apollo Care, LLC and Wells Pharma of Houston with NDC product codes 69374-314-05, 69374-314-05, 69374-314-10, 69374-314-10, 70324-102-02, 71170-925-01 and 73702-401-02.