NDC 66576-336 Gilphex

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
66576-336
Proprietary Name:
Gilphex
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
66576
Start Marketing Date: [9]
05-05-2022
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
CAPSULE (C48336)
Size(s):
8 MM
Imprint(s):
304;GIL
Score:
1

Code Structure Chart

Product Details

What is NDC 66576-336?

The NDC code 66576-336 is assigned by the FDA to the product Gilphex which is product labeled by Syntho Pharmaceuticals, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 66576-336-01 100 tablet in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Gilphex?

Do not exceed recommended doses in a  24 hour periodAdults and Children 12 years and over: 1 tablet every 4 hours. Do not exceed 6 tablets in 24 hours. Children 6 to 12 years: 1/2 tablet every 4 hours. Do not exceed 3 tablets in 24 hours. Children under 6 years of age: ask a doctor.

Which are Gilphex UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Gilphex Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Gilphex?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 2603663 - guaiFENesin 390 MG / phenylephrine HCl 10 MG Oral Tablet
  • RxCUI: 2603663 - guaifenesin 390 MG / phenylephrine hydrochloride 10 MG Oral Tablet

* Please review the disclaimer below.

Patient Education

Guaifenesin


Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
[Learn More]


Phenylephrine


Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".