NDC Compounded Drug 70004-254-40 Fentanyl Citrate; Bupivacaine Hydrochloride

Injection, Solution Epidural

Compounded Product Information
NDC Crossover Products Matching Fentanyl 2 Mcg/ml And Bupivacaine 0.125% Pf In 0.9% Sodium Chloride
Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code	70004-254
NDC Package Code	70004-254-40
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.	70004025440
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 2 Mcg/ml And Bupivacaine 0.125% Pf 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 2 Mcg/ml And Bupivacaine 0.125% Pf In 0.9% Sodium Chloride
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; Bupivacaine 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	70004
Labeler Name What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.	Sca Pharmaceuticals, Llc
Substance Name	Fentanyl Citrate; Bupivacaine Hydrochloride
Active Ingredients Information	.002 mg/1 mL; 1.25 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	2021-2

NDC Crossover Products Matching Fentanyl Citrate; Bupivacaine Hydrochloride

NDC crossover of Fentanyl 2 Mcg/ml And Bupivacaine 0.125% Pf In 0.9% Sodium Chloride with NDC 70004-254 a human compounded drug with other similar products matching the same substance name (Fentanyl Citrate; Bupivacaine 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
61141-4836-1	Fentanyl Citrate 2mcg/ml With Bupivacaine Hcl 0.1%, 150ml Bag	Fentanyl Citrate, Bupivacaine Hcl	150 mL in 1 BAG	Injection, Solution	Epidural	Medi-fare Drug
70004-231-32	Fentanyl 2 Mcg/ml And Bupivacaine 0.125% Pf In 0.9% Sodium Chloride	Fentanyl 2 Mcg/ml And Bupivacaine 0.125% Pf In 0.9% Sodium Chloride	100 mL in 1 BAG	Injection, Solution	Epidural	Sca Pharmaceuticals, Llc
70004-231-64	Fentanyl 2 Mcg/ml And Bupivacaine 0.125% Pf In 0.9% Sodium Chloride	Fentanyl 2 Mcg/ml And Bupivacaine 0.125% Pf In 0.9% Sodium Chloride	100 mL in 1 BAG	Injection, Solution	Epidural	Sca Pharmaceuticals, Llc
70004-244-40	Fentanyl 2 Mcg/ml And Bupivacaine 0.0625% Pf In 0.9% Sodium Chloride	Fentanyl 2 Mcg/ml And Bupivacaine 0.0625% Pf In 0.9% Sodium Chloride	250 mL in 1 BAG	Injection, Solution	Epidural	Sca Pharmaceuticals, Llc
70004-251-64	Fentanyl 5 Mcg/ml And Bupivacaine 0.075% Pf In 0.9% Sodium Chloride	Fentanyl 5 Mcg/ml And Bupivacaine 0.075% Pf In 0.9% Sodium Chloride	100 mL in 1 CONTAINER	Injection, Solution	Epidural	Sca Pharmaceuticals, Llc
70004-253-40	Fentanyl 2 Mcg/ml And Bupivacaine 0.1% Pf In 0.9% Sodium Chloride	Fentanyl 2 Mcg/ml And Bupivacaine 0.1% Pf In 0.9% Sodium Chloride	250 mL in 1 BAG	Injection, Solution	Epidural	Sca Pharmaceuticals, Llc
70004-289-64	Fentanyl 5 Mcg/ml And Bupivacaine 0.4% In 0.9% Sodium Chloride	Fentanyl 5 Mcg/ml And Bupivacaine 0.4% In 0.9% Sodium Chloride	100 mL in 1 CONTAINER	Injection, Solution	Epidural	Sca Pharmaceuticals, Llc

Frequently Asked Questions

What is the NDC number assigned to Fentanyl 5 Mcg/ml And Bupivacaine 0.4% In 0.9% Sodium Chloride?

Fentanyl 5 Mcg/ml And Bupivacaine 0.4% In 0.9% Sodium Chloride was assigned by its manufacturer with NDC product code 70004-254. 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 5 Mcg/ml And Bupivacaine 0.4% In 0.9% Sodium Chloride?

The NDC package code 70004-254-40 was assigned to a 250 mL in 1 BAG of fentanyl citrate; bupivacaine hydrochloride administered epidural via injection, solution.

Who manufactures this product?

Fentanyl 5 Mcg/ml And Bupivacaine 0.4% In 0.9% Sodium Chloride is manufactured by an outsourced facility and labeled by Sca Pharmaceuticals, 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 7 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by Medi-Fare Drug and SCA Pharmaceuticals, LLC with NDC product codes 61141-4836-1, 70004-231-32, 70004-231-64, 70004-244-40, 70004-251-64, 70004-253-40 and 70004-289-64.

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