NDC Compounded Drug 69194-978-10 Phenylephrine Hydrochloride

Injection Intravenous

Table of Contents

    1. Compounded Product Information
    2. NDC Crossover Products Matching 978 Phenylephrine Hcl 20mg/250ml
    3. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 69194-978
NDC Package Code 69194-978-10
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.		 69194097810
Package Description 10 BAG in 1 CASE > 250 mL in 1 BAG (69194-978-01)
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.		 978 Phenylephrine Hcl 20mg/250ml
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.		 Phenylephrine Hcl
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.		 Phenylephrine Hydrochloride
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 for temporary relief of congestion in the nose caused by various conditions including the common cold, sinusitis, hay fever, and allergies. It works by narrowing the blood vessels in the nose area, reducing swelling and congestion.
Dosage Form Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
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 69194
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Pine Pharmaceuticals Llc
Substance Name Phenylephrine Hydrochloride
Active Ingredients Information 20 mg/250 mL
Reporting Period 2023-2

NDC Crossover Products Matching Phenylephrine Hydrochloride

NDC crossover of 978 Phenylephrine Hcl 20mg/250ml with NDC 69194-978 a human compounded drug with other similar products matching the same substance name (Phenylephrine Hydrochloride) and the same administration route (intravenous) or dosage form (injection).

Frequently Asked Questions

What is the NDC number assigned to 980 Phenylephrine Hcl 40mg/250ml?

980 Phenylephrine Hcl 40mg/250ml was assigned by its manufacturer with NDC product code 69194-978. 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 980 Phenylephrine Hcl 40mg/250ml?

The NDC package code 69194-978-10 was assigned to a 10 BAG in 1 CASE > 250 mL in 1 BAG (69194-978-01) of phenylephrine hydrochloride administered intravenous via injection.

Who manufactures this product?

980 Phenylephrine Hcl 40mg/250ml is manufactured by an outsourced facility and labeled by Pine 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 30 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by Ssm Hlth St Clare Hosp-Fnton, SSM Health Care St. Louis d/b/a SSM Health St. Clare-Fenton, Hikma Injectables USA Inc., The Ritedose Corporation, LEESAR INC and Pine Pharmaceuticals LLC with NDC product codes 60652-0104-1, 60652-0104-1, 60652-0104-1, 60652-0104-1, 63037-173-25, 63037-173-25, 63037-173-25, 63037-173-25, 63037-174-25, 63037-174-25, 63037-174-25, 63037-174-25, 65302-505-10, 65302-505-10, 65302-505-10, 65302-506-10, 65302-506-10, 65302-506-10, 68985-049-91, 68985-049-91, 68985-049-91, 68985-049-91, 69194-974-10, 69194-974-10, 69194-974-10, 69194-979-10, 69194-979-10, 69194-979-10, 69194-980-10 and 69194-980-10.