NDC Compounded Drug 73013-1053-1 Fentanyl Citrate; Ropivacaine Hydrochloride

Injection, Solution Epidural

Compounded Product Information
NDC Crossover Products Matching Fentanyl Citrate- Ropivacaine Hcl
Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code	73013-1053
NDC Package Code	73013-1053-1
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.	73013105301
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- Ropivacaine 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, Ropivacaine Hydrochloride
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; Ropivacaine Hydrochloride
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	73013
Labeler Name What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.	Ourpharma Llc
Substance Name	Fentanyl Citrate; Ropivacaine Hydrochloride
Active Ingredients Information	2 ug/1 mL; 2 mg/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	2024-1

NDC Crossover Products Matching Fentanyl Citrate; Ropivacaine Hydrochloride

NDC crossover of Fentanyl Citrate- Ropivacaine Hcl with NDC 73013-1053 a human compounded drug with other similar products matching the same substance name (Fentanyl Citrate; Ropivacaine Hydrochloride) and the same administration route (epidural) or dosage form (injection, solution).

NDC	Proprietary Name	Non-Proprietary Name	Package Desc	Dosage Form	Route Name	Company Name
70004-260-32	Fentanyl 2 Mcg/ml And Ropivacaine 0.2% In 0.9% Sodium Chloride Pf	Fentanyl 2 Mcg/ml And Ropivacaine 0.2% In 0.9% Sodium Chloride Pf	100 mL in 1 BAG	Injection, Solution	Epidural	Sca Pharmaceuticals, Llc
70004-260-32	Fentanyl 2 Mcg/ml And Ropivacaine 0.2% In 0.9% Sodium Chloride Pf	Fentanyl 2 Mcg/ml And Ropivacaine 0.2% In 0.9% Sodium Chloride Pf	100 mL in 1 BAG	Injection, Solution	Epidural	Sca Pharmaceuticals, Llc
70004-264-22	Fentanyl 2 Mcg/ml And Ropivacaine 0.1% In 0.9% Sodium Chloride Pf	Fentanyl 2 Mcg/ml And Ropivacaine 0.1% In 0.9% Sodium Chloride Pf	50 mL in 1 SYRINGE	Injection, Solution	Epidural	Sca Pharmaceuticals, Llc
70004-264-22	Fentanyl 2 Mcg/ml And Ropivacaine 0.1% In 0.9% Sodium Chloride Pf	Fentanyl 2 Mcg/ml And Ropivacaine 0.1% In 0.9% Sodium Chloride Pf	50 mL in 1 SYRINGE	Injection, Solution	Epidural	Sca Pharmaceuticals, Llc
73013-1050-1	Fentanyl Citrate- Ropivacaine Hcl	Fentanyl Citrate, Ropivacaine Hydrochloride	100 mL in 1 BAG	Injection, Solution	Epidural	Ourpharma Llc
73013-1052-1	Fentanyl Citrate- Ropivacaine Hcl	Fentanyl Citrate, Ropivacaine Hydrochloride	150 mL in 1 BAG	Injection, Solution	Epidural	Ourpharma Llc

Frequently Asked Questions

What is the NDC number assigned to Fentanyl Citrate- Ropivacaine Hcl?

Fentanyl Citrate- Ropivacaine Hcl was assigned by its manufacturer with NDC product code 73013-1053. 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- Ropivacaine Hcl?

The NDC package code 73013-1053-1 was assigned to a 250 mL in 1 BAG of fentanyl citrate; ropivacaine hydrochloride administered epidural via injection, solution.

Who manufactures this product?

Fentanyl Citrate- Ropivacaine Hcl is manufactured by an outsourced facility and labeled by Ourpharma 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 6 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by SCA Pharmaceuticals, LLC and OurPharma LLC with NDC product codes 70004-260-32, 70004-260-32, 70004-264-22, 70004-264-22, 73013-1050-1 and 73013-1052-1.

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