NDC Compounded Drug 70092-103-36 Fentanyl Citrate; Bupivacaine Hydrochloride Anhydrous

Injection Epidural

Table of Contents

    1. Compounded Product Information
    2. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 70092-103
NDC Package Code 70092-103-36
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.		 70092010336
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.		 Fent 2 Mcg/ml-bup 0.1% Pf 100ml Ns Ivb
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.		 Fent 2 Mcg/ml-bup 0.1% Pf 100ml Ns Ivb
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 Citrate; Bupivacaine Hydrochloride Anhydrous
Dosage Form Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Route Name Epidural - Administration upon or over the dura mater.
Marketing Category OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Code 70092
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Quva Pharma, Inc.
Substance Name Fentanyl Citrate; Bupivacaine Hydrochloride Anhydrous
Active Ingredients Information 200 ug/100 mL; 100 mg/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 2022-2

Frequently Asked Questions

What is the NDC number assigned to Fent 2 Mcg/ml-bup 0.1% Pf 100ml Ns Ivb?

Fent 2 Mcg/ml-bup 0.1% Pf 100ml Ns Ivb was assigned by its manufacturer with NDC product code 70092-103. 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 Fent 2 Mcg/ml-bup 0.1% Pf 100ml Ns Ivb?

The NDC package code 70092-103-36 was assigned to a 100 mL in 1 BAG of fentanyl citrate; bupivacaine hydrochloride anhydrous administered epidural via injection.

Who manufactures this product?

Fent 2 Mcg/ml-bup 0.1% Pf 100ml Ns Ivb is manufactured by an outsourced facility and labeled by Quva 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.