NDC Compounded Drug 70324-677-01 Fentanyl; Bupivacaine

Injection, Solution Epidural

Table of Contents

    1. Compounded Product Information
    2. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 70324-677
NDC Package Code 70324-677-01
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.		 70324067701
Package Description 100 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.		 200 Mcg Fentanyl And 0.125% Bupivacaine Hcl In 0.9% Nacl
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.		 Fentanyl Epidural
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.		 Fentanyl; Bupivacaine
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 Epidural - Administration upon or over the dura mater.
Marketing Category OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Code 70324
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Sterrx Llc
Substance Name Fentanyl; Bupivacaine
Active Ingredients Information 200 ug/100 mL; 1.25 g/100 mL
DEA Schedule What is the Drug Enforcement Administration (DEA) CII Schedule?
The controlled substances in the CII schedule have a high abuse potential with severe psychological or physical dependence liability, but have accepted medical use in the United States. Schedule CII controlled substances include certain narcotic, stimulant, and depressant drugs. 		Schedule II (CII) Substances
Reporting Period 2023-1

Frequently Asked Questions

What is the NDC number assigned to 200 Mcg Fentanyl And 0.125% Bupivacaine Hcl In 0.9% Nacl?

200 Mcg Fentanyl And 0.125% Bupivacaine Hcl In 0.9% Nacl was assigned by its manufacturer with NDC product code 70324-677. 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 200 Mcg Fentanyl And 0.125% Bupivacaine Hcl In 0.9% Nacl?

The NDC package code 70324-677-01 was assigned to a 100 mL in 1 BAG of fentanyl; bupivacaine administered epidural via injection, solution.

Who manufactures this product?

200 Mcg Fentanyl And 0.125% Bupivacaine Hcl In 0.9% Nacl is manufactured by an outsourced facility and labeled by Sterrx Llc. 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.