NDC 63868-391 Guaifenesin And Dextromethorphan Hydrobromide

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:
63868-391
Proprietary Name:
Guaifenesin And Dextromethorphan Hydrobromide
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Chain Drug Marketing Association Inc
Labeler Code:
63868
Start Marketing Date: [9]
12-10-2017
Listing Expiration Date: [11]
12-31-2020
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
OVAL (C48345)
Size(s):
22 MM
Imprint(s):
MUCINEX;1200
Score:
1

Product Packages

NDC Code 63868-391-14

Package Description: 2 BLISTER PACK in 1 CARTON / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Product Details

What is NDC 63868-391?

The NDC code 63868-391 is assigned by the FDA to the product Guaifenesin And Dextromethorphan Hydrobromide which is product labeled by Chain Drug Marketing Association Inc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 63868-391-14 2 blister pack in 1 carton / 14 tablet, extended release in 1 blister pack. 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 And Dextromethorphan Hydrobromide?

•do not crush, chew, or break tablet•take with a full glass of water•this product can be administered without regard for timing of meals•adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours•children under 12 years of age: do not use

Which are Guaifenesin And Dextromethorphan Hydrobromide UNII Codes?

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

Which are Guaifenesin And Dextromethorphan Hydrobromide 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:

  • CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

What is the NDC to RxNorm Crosswalk for Guaifenesin And Dextromethorphan Hydrobromide?

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: 1099074 - guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1099074 - 12 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral Tablet
  • RxCUI: 1099074 - dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral Tablet

* 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".