Pseudoephedrine Hcl Tablet, Extended Release
NDC 58602-804
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Pseudoephedrine Hcl is a ANDA-approved product labeled by Aurohealth Llc. Pseudoephedrine is used for the temporary relief of stuffy nose and sinus pain/pressure caused by infection (such as the common cold, flu) or other breathing illnesses (such as hay fever, allergies, bronchitis). It is supplied as a white tablet, extended release for oral administration. This product entry covers the primary NDC 58602-804 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
58602-804
Proprietary Name:
Pseudoephedrine Hcl
Non-Proprietary Name: [1]
Pseudoephedrine Hcl
Substance Name: [2]
Pseudoephedrine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Tablet, Extended Release
- A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
58602
Product Label ID:
FDA Application Number: [6]
ANDA209008
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
06-09-2017
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Product Characteristics
Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
Shape:
CAPSULE (C48336)
Size(s):
18 MM
Imprint(s):
70;T
Score:
1
Code Structure Chart
Product Details
What is NDC 58602-804?
The NDC code 58602-804 is assigned by the FDA to the product Pseudoephedrine Hcl. This pharmaceutical product is labeled by Aurohealth Llc and is currently categorized as listed product. The medication is a tablet, extended release administered via oral route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 58602-804-67, 58602-804-83. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
Pseudoephedrine is used for the temporary relief of stuffy nose and sinus pain/pressure caused by infection (such as the common cold, flu) or other breathing illnesses (such as hay fever, allergies, bronchitis). Pseudoephedrine is a decongestant (sympathomimetic). It works by narrowing the blood vessels to decrease swelling and congestion. If you are self-treating with this medication, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist. (See also Precautions section.) Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Do not use this product in children younger than 6 years unless specifically directed by the doctor. Long-acting tablets/capsules are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar decongestants (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).
What are Active Ingredients of this product?
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.
- PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 - A phenethylamine that is an isomer of EPHEDRINE which has less central nervous system effects and usage is mainly for respiratory tract decongestion.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N)
- PSEUDOEPHEDRINE (UNII: 7CUC9DDI9F) (Active Moiety)
Which are the Inactive Ingredients associated 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:
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
- HYDROXYPROPYL CELLULOSE (120000 MW) (UNII: UKE75GEA7F)
- HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)
- HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)
- HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
- LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- TALC (UNII: 7SEV7J4R1U)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
What is the NDC to RxNorm Crosswalk for this product?
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: 1049154 - pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet
- RxCUI: 1049154 - 12 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet
- RxCUI: 1049154 - pseudoephedrine HCl 120 MG 12 HR Extended Release Oral Tablet
Which are the Pharmacologic Classes of this product?
A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.
* Please review the full disclaimer at the bottom of this page.
Patient Education
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.
[Learn More]
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
