NDC 77333-360 Guaifenesin 400mg Caplets

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:
77333-360
Proprietary Name:
Guaifenesin 400mg Caplets
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Gendose Pharmaceuticals, Llc
Labeler Code:
77333
Start Marketing Date: [9]
09-02-2022
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
CAPSULE (C48336)
Size(s):
14 MM
Imprint(s):
G400
Score:
1

Product Packages

NDC Code 77333-360-10

Package Description: 100 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK (77333-360-25)

Product Details

What is NDC 77333-360?

The NDC code 77333-360 is assigned by the FDA to the product Guaifenesin 400mg Caplets which is product labeled by Gendose Pharmaceuticals, Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 77333-360-10 100 blister pack in 1 box / 1 tablet in 1 blister pack (77333-360-25). 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 Guaifenesin 400mg Caplets?

ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER TAKE 1 CAPLET EVERY 4 HOURS WITH A FULL GLASS OF WATER WHILE SYMPTOMS PERSIST. CHILDREN UNDER 12 YEARS OF AGE DO NOT USE.

Which are Guaifenesin 400mg Caplets UNII Codes?

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

Which are Guaifenesin 400mg Caplets 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 Guaifenesin 400mg Caplets?

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:

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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.
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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".