NDC Compounded Drug 70324-327-02 Fentanyl

Injection, Solution Intravenous

Table of Contents

    1. Compounded Product Information
    2. NDC Crossover Products Matching Fentanyl In 0.9% Sodium Chloride
    3. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 70324-327
NDC Package Code 70324-327-02
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.		 70324032702
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 In 0.9% Sodium Chloride
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
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
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 severe ongoing pain (such as due to cancer). 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. Do not use the patch form of fentanyl to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.
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 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
Active Ingredients Information 10 ug/1 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 Fentanyl

NDC crossover of Fentanyl In 0.9% Sodium Chloride with NDC 70324-327 a human compounded drug with other similar products matching the same substance name (Fentanyl) and the same administration route (intravenous) or dosage form (injection, solution).

Frequently Asked Questions

What is the NDC number assigned to Fentanyl Citrate?

Fentanyl Citrate was assigned by its manufacturer with NDC product code 70324-327. 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 70324-327-02 was assigned to a 250 mL in 1 BAG of fentanyl administered intravenous via injection, solution.

Who manufactures this product?

Fentanyl Citrate 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.

Which are the NDC crossover matchings for this product?

We found 22 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by PROVIDENCE INFUSION HOSPITAL SERVICES, SterRx LLC and Wells Pharma of Houston with NDC product codes 70214-3020-1, 70214-3020-1, 70214-3020-1, 70214-3020-1, 70214-5010-1, 70214-5010-1, 70214-5010-1, 70214-5010-1, 70324-327-01, 70324-327-01, 73702-202-02, 73702-202-02, 73702-202-02, 73702-202-02, 73702-202-03, 73702-202-03, 73702-202-03, 73702-202-03, 73702-202-15, 73702-203-02, 73702-203-02 and 73702-203-65.