NDC 62542-301 Hydrocodone Polistirex And Chlorpheniramine Polistirex
Suspension, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
Code Structure Chart
Product Details
What is NDC 62542-301?
What are the uses for Hydrocodone Polistirex And Chlorpheniramine Polistirex?
What are Hydrocodone Polistirex And Chlorpheniramine Polistirex Active Ingredients?
- CHLORPHENIRAMINE 8 mg/5mL - A histamine H1 antagonist used in allergic reactions, hay fever, rhinitis, urticaria, and asthma. It has also been used in veterinary applications. One of the most widely used of the classical antihistaminics, it generally causes less drowsiness and sedation than PROMETHAZINE.
- HYDROCODONE 10 mg/5mL - Narcotic analgesic related to CODEINE, but more potent and more addicting by weight. It is used also as cough suppressant.
Which are Hydrocodone Polistirex And Chlorpheniramine Polistirex UNII Codes?
The UNII codes for the active ingredients in this product are:
- HYDROCODONE (UNII: 6YKS4Y3WQ7)
- HYDROCODONE (UNII: 6YKS4Y3WQ7) (Active Moiety)
- CHLORPHENIRAMINE (UNII: 3U6IO1965U)
- CHLORPHENIRAMINE (UNII: 3U6IO1965U) (Active Moiety)
Which are Hydrocodone Polistirex And Chlorpheniramine Polistirex 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:
- WATER (UNII: 059QF0KO0R)
- HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
- SUCROSE (UNII: C151H8M554)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- XANTHAN GUM (UNII: TTV12P4NEE)
- CORN OIL (UNII: 8470G57WFM)
- METHYLPARABEN (UNII: A2I8C7HI9T)
- POLYSORBATE 80 (UNII: 6OZP39ZG8H)
- ASCORBIC ACID (UNII: PQ6CK8PD0R)
- PROPYLPARABEN (UNII: Z8IX2SC1OH)
- ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
- SORBITOL (UNII: 506T60A25R)
- DIBUTYL SEBACATE (UNII: 4W5IH7FLNY)
- D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
- FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
- SODIUM BENZOATE (UNII: OJ245FE5EU)
- PHOSPHORIC ACID (UNII: E4GA8884NN)
What is the NDC to RxNorm Crosswalk for Hydrocodone Polistirex And Chlorpheniramine Polistirex?
- RxCUI: 1087459 - HYDROcodone polistirex 10 MG / chlorpheniramine polistirex 8 MG in 5 mL 12HR Extended Release Oral Suspension
- RxCUI: 1087459 - 12 HR chlorpheniramine polistirex 1.6 MG/ML / hydrocodone polistirex 2 MG/ML Extended Release Suspension
- RxCUI: 1087459 - hydrocodone polistirex 10 MG / chlorpheniramine polistirex 8 MG per 5 ML 12HR Extended Release Oral Suspension
Which are the Pharmacologic Classes for Hydrocodone Polistirex And Chlorpheniramine Polistirex?
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Patient Education
Chlorpheniramine
Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
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Hydrocodone Combination Products
Hydrocodone is available in combination with other ingredients, and different combination products are prescribed for different uses. Some hydrocodone combination products are used to relieve moderate-to-severe pain. Other hydrocodone combination products are used to relieve cough. Hydrocodone is in a class of medications called opiate (narcotic) analgesics and in a class of medications called antitussives. Hydrocodone relieves pain by changing the way the brain and nervous system respond to pain. Hydrocodone relieves cough by decreasing activity in the part of the brain that causes coughing. You will take hydrocodone in combination with at least one other medication, but this monograph only provides information about hydrocodone. Be sure to read information about the other ingredients in the hydrocodone product you are taking. Ask your doctor or pharmacist if you have any questions.
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[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.
[7] What is the Drug Enforcement Administration (DEA) CII Schedule? - This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.
[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.
[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
[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".