NDC 51316-009 Guaifenesin And Dextromethorphan Hbr
Tablet, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
GREEN (C48329 - LIGHT GREEN TO GREEN)
Code Structure Chart
Product Details
What is NDC 51316-009?
What are the uses for Guaifenesin And Dextromethorphan Hbr?
What are Guaifenesin And Dextromethorphan Hbr Active Ingredients?
- DEXTROMETHORPHAN HYDROBROMIDE 30 mg/1 - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
- GUAIFENESIN 600 mg/1 - An expectorant that also has some muscle relaxing action. It is used in many cough preparations.
Which are Guaifenesin And Dextromethorphan Hbr UNII Codes?
The UNII codes for the active ingredients in this product are:
- GUAIFENESIN (UNII: 495W7451VQ)
- GUAIFENESIN (UNII: 495W7451VQ) (Active Moiety)
- DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH)
- DEXTROMETHORPHAN (UNII: 7355X3ROTS) (Active Moiety)
Which are Guaifenesin And Dextromethorphan Hbr 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 CROSSLINKED) (UNII: HHT01ZNK31)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
- HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)
- HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
What is the NDC to RxNorm Crosswalk for Guaifenesin And Dextromethorphan Hbr?
- RxCUI: 1298324 - guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral Tablet
- RxCUI: 1298324 - 12 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral Tablet
- RxCUI: 1298324 - dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral Tablet
Which are the Pharmacologic Classes for Guaifenesin And Dextromethorphan Hbr?
- Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
- Expectorant - [EPC] (Established Pharmacologic Class)
- Increased Respiratory Secretions - [PE] (Physiologic Effect)
- Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
- Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
- Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
* Please review the disclaimer below.
[1] 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.
[2] 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.
[3] 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.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
[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".