NDC Compounded Drug 69374-924-05 Rocuronium Bromide

Injection, Solution Intravenous

Compounded Product Information
NDC Crossover Products Matching Rocuronium Bromide 10 Mg/ml
Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code	69374-924
NDC Package Code	69374-924-05
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.	69374092405
Package Description	6 CARTON in 1 CASE > 5 SYRINGE, PLASTIC in 1 CARTON > 5 mL in 1 SYRINGE, PLASTIC
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.	Rocuronium Bromide 10 Mg/ml
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.	Rocuronium Bromide 10 Mg/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.	Rocuronium Bromide
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	69374
Labeler Name What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.	Nephron Sterile Compounding Center, Llc
Substance Name	Rocuronium Bromide
Active Ingredients Information	10 mg/1 mL
Reporting Period	2024-1

NDC Crossover Products Matching Rocuronium Bromide

NDC crossover of Rocuronium Bromide 10 Mg/ml with NDC 69374-924 a human compounded drug with other similar products matching the same substance name (Rocuronium Bromide) and the same administration route (intravenous) or dosage form (injection, solution).

NDC	Proprietary Name	Non-Proprietary Name	Package Desc	Dosage Form	Route Name	Company Name
70004-850-09	Rocuronium 10 Mg/ml	Rocuronium 10 Mg/ml	5 mL in 1 SYRINGE	Injection, Solution	Intravenous	Sca Pharmaceuticals, Llc
70004-850-09	Rocuronium 10 Mg/ml	Rocuronium 10 Mg/ml	5 mL in 1 SYRINGE	Injection, Solution	Intravenous	Sca Pharmaceuticals, Llc
70004-850-12	Rocuronium 10 Mg/ml	Rocuronium 10 Mg/ml	10 mL in 1 SYRINGE	Injection, Solution	Intravenous	Sca Pharmaceuticals, Llc
70004-850-12	Rocuronium 10 Mg/ml	Rocuronium 10 Mg/ml	10 mL in 1 SYRINGE	Injection, Solution	Intravenous	Sca Pharmaceuticals, Llc
71449-004-11	Rocuronium Bromide	Rocuronium Bromide	5 mL in 1 SYRINGE, PLASTIC	Injection, Solution	Intravenous	Denver Solutions, Llc Dba Leiters Health
71449-004-11	Rocuronium Bromide	Rocuronium Bromide	5 mL in 1 SYRINGE, PLASTIC	Injection, Solution	Intravenous	Denver Solutions, Llc Dba Leiters Health
71449-004-15	Rocuronium Bromide	Rocuronium Bromide	10 mL in 1 SYRINGE, PLASTIC	Injection, Solution	Intravenous	Denver Solutions, Llc Dba Leiters Health
71449-004-15	Rocuronium Bromide	Rocuronium Bromide	10 mL in 1 SYRINGE, PLASTIC	Injection, Solution	Intravenous	Denver Solutions, Llc Dba Leiters Health

Frequently Asked Questions

What is the NDC number assigned to Rocuronium Bromide?

Rocuronium Bromide was assigned by its manufacturer with NDC product code 69374-924. 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 Rocuronium Bromide?

The NDC package code 69374-924-05 was assigned to a 6 CARTON in 1 CASE > 5 SYRINGE, PLASTIC in 1 CARTON > 5 mL in 1 SYRINGE, PLASTIC of rocuronium bromide administered intravenous via injection, solution.

Who manufactures this product?

Rocuronium Bromide is manufactured by an outsourced facility and labeled by Nephron Sterile Compounding Center, 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 8 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by SCA Pharmaceuticals, LLC and Denver Solutions, LLC dba Leiters Health with NDC product codes 70004-850-09, 70004-850-09, 70004-850-12, 70004-850-12, 71449-004-11, 71449-004-11, 71449-004-15 and 71449-004-15.

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