NDC 63629-2353 Alfuzosin Hydrochloride
Tablet, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 63629 - Bryant Ranch Prepack
- 63629-2353 - Alfuzosin Hydrochloride
Product Characteristics
Product Packages
NDC Code 63629-2353-1
Package Description: 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Details
What is NDC 63629-2353?
What are the uses for Alfuzosin Hydrochloride?
What are Alfuzosin Hydrochloride Active Ingredients?
Which are Alfuzosin Hydrochloride UNII Codes?
The UNII codes for the active ingredients in this product are:
- ALFUZOSIN HYDROCHLORIDE (UNII: 75046A1XTN)
- ALFUZOSIN (UNII: 90347YTW5F) (Active Moiety)
Which are Alfuzosin Hydrochloride 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:
- STARCH, CORN (UNII: O8232NY3SJ)
- HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
- DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- TALC (UNII: 7SEV7J4R1U)
- HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
What is the NDC to RxNorm Crosswalk for Alfuzosin Hydrochloride?
- RxCUI: 861132 - alfuzosin HCl 10 MG 24HR Extended Release Oral Tablet
- RxCUI: 861132 - 24 HR alfuzosin hydrochloride 10 MG Extended Release Oral Tablet
- RxCUI: 861132 - alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral Tablet
Which are the Pharmacologic Classes for Alfuzosin Hydrochloride?
* Please review the disclaimer below.
Patient Education
Alfuzosin
Alfuzosin is used in men to treat symptoms of an enlarged prostate (benign prostatic hyperplasia or BPH), which include difficulty urinating (hesitation, dribbling, weak stream, and incomplete bladder emptying), painful urination, and urinary frequency and urgency. Alfuzosin is in a class of medications called alpha blockers. It works by relaxing the muscles in the prostate and bladder to allow urine to flow more easily.
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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.
[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".