NDC Compounded Drug 63037-107-05 Bupivacaine Hydrochloride; Fentanyl Citrate

Injection Epidural

Table of Contents

    1. Compounded Product Information
    2. NDC Crossover Products Matching Fentanyl Citrate, Bupivacaine Hcl
    3. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 63037-107
NDC Package Code 63037-107-05
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.		 63037010705
Package Description 250 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.		 Fentanyl Citrate, Bupivacaine Hcl
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 Citrate, Bupivacaine 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.		 Bupivacaine Hydrochloride; Fentanyl Citrate
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 63037
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Hikma Injectables Usa Inc.
Substance Name Bupivacaine Hydrochloride; Fentanyl Citrate
Active Ingredients Information 312.5 mg/250 mL; 500 ug/250 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

NDC Crossover Products Matching Bupivacaine Hydrochloride; Fentanyl Citrate

NDC crossover of Fentanyl Citrate, Bupivacaine Hcl with NDC 63037-107 a human compounded drug with other similar products matching the same substance name (Bupivacaine Hydrochloride; Fentanyl Citrate) and the same administration route (epidural) or dosage form (injection).

Frequently Asked Questions

What is the NDC number assigned to Fentanyl Citrate, Bupivacaine Hcl?

Fentanyl Citrate, Bupivacaine Hcl was assigned by its manufacturer with NDC product code 63037-107. 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 Fentanyl Citrate, Bupivacaine Hcl?

The NDC package code 63037-107-05 was assigned to a 250 mL in 1 BAG of bupivacaine hydrochloride; fentanyl citrate administered epidural via injection.

Who manufactures this product?

Fentanyl Citrate, Bupivacaine Hcl is manufactured by an outsourced facility and labeled by Hikma Injectables Usa 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 Hikma Injectables USA Inc. with NDC product codes 63037-106-05 and 63037-106-05.