NDC Compounded Drug 51754-9160-1 Fentanyl Citrate

Injection Intravenous

Table of Contents

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

Compounded Drug Product Information

NDC Product Code 51754-9160
NDC Package Code 51754-9160-1
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.		 51754916001
Package Description 100 mL in 1 VIAL, GLASS
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
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 Injection 5000 Mcg/100 Ml
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
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 help relieve sudden (breakthrough) cancer pain in people who are regularly taking moderate to large amounts of opioid pain medication. Fentanyl belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. This medication should not be used to relieve mild or short-term pain (such as due to headache/migraine, dental procedures, surgery).
Dosage Form Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
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 51754
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Exela Pharma Sciences, Llc.
Substance Name Fentanyl Citrate
Active Ingredients Information 5000 ug/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 2021-2

NDC Crossover Products Matching Fentanyl Citrate

NDC crossover of Fentanyl Citrate with NDC 51754-9160 a human compounded drug with other similar products matching the same substance name (Fentanyl Citrate) and the same administration route (intravenous) or dosage form (injection).

Frequently Asked Questions

What is the NDC number assigned to Fentanyl Citrate?

Fentanyl Citrate was assigned by its manufacturer with NDC product code 51754-9160. 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?

The NDC package code 51754-9160-1 was assigned to a 100 mL in 1 VIAL, GLASS of fentanyl citrate administered intravenous via injection.

Who manufactures this product?

Fentanyl Citrate is manufactured by an outsourced facility and labeled by Exela Pharma Sciences, 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.

Which are the NDC crossover matchings for this product?

We found 12 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by Ssm Hlth St Clare Hosp-Fnton, IntegraDose Compounding Services, LLC and STAQ Pharma Inc with NDC product codes 60652-6030-1, 60652-9010-1, 71139-6030-1, 71139-6030-1, 73177-102-01, 73177-102-02, 73177-102-03, 73177-102-05, 73177-103-04, 73177-103-05, 73177-103-07 and 73177-103-16.