NDC 36800-611 Topcare Allergy And Congestion Relief
Loratadine,Pseudoephedrine Sulfate Tablet, Film Coated, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
Code Structure Chart
Product Details
What is NDC 36800-611?
What are the uses for Topcare Allergy And Congestion Relief?
What are Topcare Allergy And Congestion Relief Active Ingredients?
- LORATADINE 5 mg/1 - A second-generation histamine H1 receptor antagonist used in the treatment of allergic rhinitis and urticaria. Unlike most classical antihistamines (HISTAMINE H1 ANTAGONISTS) it lacks central nervous system depressing effects such as drowsiness.
- PSEUDOEPHEDRINE SULFATE 120 mg/1
Which are Topcare Allergy And Congestion Relief UNII Codes?
The UNII codes for the active ingredients in this product are:
- LORATADINE (UNII: 7AJO3BO7QN)
- LORATADINE (UNII: 7AJO3BO7QN) (Active Moiety)
- PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B)
- PSEUDOEPHEDRINE (UNII: 7CUC9DDI9F) (Active Moiety)
Which are Topcare Allergy And Congestion Relief 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:
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
- HYPROMELLOSES (UNII: 3NXW29V3WO)
- LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- POVIDONE (UNII: FZ989GH94E)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
What is the NDC to RxNorm Crosswalk for Topcare Allergy And Congestion Relief?
- RxCUI: 1242399 - pseudoephedrine sulfate 120 MG / loratadine 5 MG 12HR Extended Release Oral Tablet
- RxCUI: 1242399 - 12 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet
- RxCUI: 1242399 - loratadine 5 MG / pseudoephedrine sulfate 120 MG 12 HR Extended Release Oral Tablet
Which are the Pharmacologic Classes for Topcare Allergy And Congestion Relief?
* Please review the disclaimer below.
Patient Education
Loratadine
Loratadine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and other allergies. These symptoms include sneezing, runny nose, and itchy eyes, nose, or throat. Loratadine is also used to treat itching and redness caused by hives. However, loratadine does not prevent hives or other allergic skin reactions. Loratadine 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. Loratadine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of loratadine alone. If you are taking the loratadine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.
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Pseudoephedrine
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.
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* 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".