NDC Compounded Drug 60652-4272-1 Fentanyl Citrate; Ropivacaine Hydrochloride

Injection Epidural

Compounded Product Information
NDC Crossover Products Matching Fentanyl/ropivacaine
Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code	60652-4272
NDC Package Code	60652-4272-1
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.	60652427201
Package Description	150 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/ropivacaine
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/ropivacaine
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 - 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	60652
Labeler Name What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.	Ssm Hlth St Clare Hosp-fnton
Substance Name	Fentanyl Citrate; Ropivacaine Hydrochloride
Active Ingredients Information	.002 mg/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	2023-1

NDC Crossover Products Matching Fentanyl Citrate; Ropivacaine Hydrochloride

NDC crossover of Fentanyl/ropivacaine with NDC 60652-4272 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).

NDC	Proprietary Name	Non-Proprietary Name	Package Desc	Dosage Form	Route Name	Company Name
70092-108-36	Fent 2 Mcg/ml-ropiv 0.2% Pf 100ml Ns Ivb	Fent 2 Mcg/ml-ropiv 0.2% Pf 100ml Ns Ivb	100 mL in 1 BAG	Injection	Epidural	Quva Pharma, Inc.
70092-108-36	Fent 2 Mcg/ml-ropiv 0.2% Pf 100ml Ns Ivb	Fent 2 Mcg/ml-ropiv 0.2% Pf 100ml Ns Ivb	100 mL in 1 BAG	Injection	Epidural	Quva Pharma, Inc.
70092-108-36	Fent 2 Mcg/ml-ropiv 0.2% Pf 100ml Ns Ivb	Fent 2 Mcg/ml-ropiv 0.2% Pf 100ml Ns Ivb	100 mL in 1 BAG	Injection	Epidural	Quva Pharma, Inc.
70092-108-36	Fent 2 Mcg/ml-ropiv 0.2% Pf 100ml Ns Ivb	Fent 2 Mcg/ml-ropiv 0.2% Pf 100ml Ns Ivb	100 mL in 1 BAG	Injection	Epidural	Quva Pharma, Inc.
70092-207-37	Fent2mcg/ml-ropiv0.1%pf 200ml Ns- 250ivb	Fent2mcg/ml-ropiv0.1%pf 200ml Ns- 250ivb	200 mL in 1 CARTRIDGE	Injection	Epidural	Quva Pharma, Inc.
70092-225-37	Fent 2 Mcg/ml-ropiv 0.2% Pf 250ml Ns Ivb	Fent 2 Mcg/ml-ropiv 0.2% Pf 250ml Ns Ivb	250 mL in 1 BAG	Injection	Epidural	Quva Pharma, Inc.
70092-225-37	Fent 2 Mcg/ml-ropiv 0.2% Pf 250ml Ns Ivb	Fent 2 Mcg/ml-ropiv 0.2% Pf 250ml Ns Ivb	250 mL in 1 BAG	Injection	Epidural	Quva Pharma, Inc.
70092-399-75	Fent2mcg/ml-rop0.1% Pf100mlns Cadd-yfsff	Fent2mcg/ml-rop0.1% Pf100mlns Cadd-yfsff	200 mL in 1 CARTRIDGE	Injection	Epidural	Quva Pharma, Inc.
70092-399-75	Fent2mcg/ml-rop0.1% Pf100mlns Cadd-yfsff	Fent2mcg/ml-rop0.1% Pf100mlns Cadd-yfsff	200 mL in 1 CARTRIDGE	Injection	Epidural	Quva Pharma, Inc.
70092-441-76	Fent2mcg/ml-rop0.1% Pf200mlns Cadd-yfsff	Fent2mcg/ml-rop0.1% Pf200mlns Cadd-yfsff	200 mL in 1 CARTRIDGE	Injection	Epidural	Quva Pharma, Inc.
70092-441-76	Fent2mcg/ml-rop0.1% Pf200mlns Cadd-yfsff	Fent2mcg/ml-rop0.1% Pf200mlns Cadd-yfsff	200 mL in 1 CARTRIDGE	Injection	Epidural	Quva Pharma, Inc.
70092-441-76	Fent2mcg/ml-rop0.1% Pf200mlns Cadd-yfsff	Fent2mcg/ml-rop0.1% Pf200mlns Cadd-yfsff	200 mL in 1 CARTRIDGE	Injection	Epidural	Quva Pharma, Inc.
70092-441-76	Fent2mcg/ml-rop0.1% Pf200mlns Cadd-yfsff	Fent2mcg/ml-rop0.1% Pf200mlns Cadd-yfsff	200 mL in 1 CARTRIDGE	Injection	Epidural	Quva Pharma, Inc.
70092-504-36	Fent 2 Mcg/ml-ropiv 0.2% Pf 100ml Ns Ivb	Fent 2 Mcg/ml-ropiv 0.2% Pf 100ml Ns Ivb	100 mL in 1 BAG	Injection	Epidural	Quva Pharma, Inc.
70092-504-36	Fent 2 Mcg/ml-ropiv 0.2% Pf 100ml Ns Ivb	Fent 2 Mcg/ml-ropiv 0.2% Pf 100ml Ns Ivb	100 mL in 1 BAG	Injection	Epidural	Quva Pharma, Inc.
70092-504-36	Fent 2 Mcg/ml-ropiv 0.2% Pf 100ml Ns Ivb	Fent 2 Mcg/ml-ropiv 0.2% Pf 100ml Ns Ivb	100 mL in 1 BAG	Injection	Epidural	Quva Pharma, Inc.

Frequently Asked Questions

What is the NDC number assigned to Fent 2 Mcg/ml-ropiv 0.2% Pf 100ml Ns Ivb?

Fent 2 Mcg/ml-ropiv 0.2% Pf 100ml Ns Ivb was assigned by its manufacturer with NDC product code 60652-4272. 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-ropiv 0.2% Pf 100ml Ns Ivb?

The NDC package code 60652-4272-1 was assigned to a 150 mL in 1 BAG of fentanyl citrate; ropivacaine hydrochloride administered epidural via injection.

Who manufactures this product?

Fent 2 Mcg/ml-ropiv 0.2% Pf 100ml Ns Ivb is manufactured by an outsourced facility and labeled by Ssm Hlth St Clare Hosp-fnton. 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 16 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by QuVa Pharma, Inc. with NDC product codes 70092-108-36, 70092-108-36, 70092-108-36, 70092-108-36, 70092-207-37, 70092-225-37, 70092-225-37, 70092-399-75, 70092-399-75, 70092-441-76, 70092-441-76, 70092-441-76, 70092-441-76, 70092-504-36, 70092-504-36 and 70092-504-36.

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