NDC 0009-0090 Xanax
Alprazolam Tablet Oral

Table of Contents

    1. Product Information
    2. Product Packages
    3. Product Characteristics
    4. What is NDC 0009-0090?
    5. Xanax Uses
    6. Active Ingredients
    7. Active Ingredients UNII Codes
    8. Inactive Ingredients UNII Codes
    9. Pharmacologic Classes
    10. Patient Education

Product Information

NDC Product Code0009-0090
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Xanax
Non-Proprietary Name 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.		Alprazolam
Substance Name 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.		Alprazolam
Product Type 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.		Human Prescription Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormTablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Pharmacia & Upjohn Company Llc
Labeler Code0009
SPL SET ID:388e249d-b9b6-44c3-9f8f-880eced0239f
FDA Application Number 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.		NDA018276
DEA Schedule What is the Drug Enforcement Administration (DEA) CIV Schedule?
The controlled substances in the CIV schedule have an abuse potential and dependence liability less than those listed in CIII and have an accepted medical use in the United States. 		Schedule IV (CIV) Substances
Marketing Category 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.		NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		10-16-1981
Listing Expiration Date 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.		12-31-2024
Exclude Flag 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". 		N
NDC Code Structure

Product Characteristics

Color(s)WHITE (C48325)
ORANGE (C48331)
BLUE (C48333)
ShapeOVAL (C48345)
Size(s)9 MM
Imprint(s)XANAX;0;25
XANAX;0;5
XANAX;1;0
Score2

Product Packages

NDC Code 0009-0090-01

Package Description: 100 TABLET in 1 BOTTLE

Price per Unit: $8.23306 per EA

NDC Code 0009-0090-04

Package Description: 500 TABLET in 1 BOTTLE

Price per Unit: $8.23306 per EA

Product Details

What is NDC 0009-0090?

The NDC code 0009-0090 is assigned by the FDA to the product Xanax which is a human prescription drug product labeled by Pharmacia & Upjohn Company Llc. The generic name of Xanax is alprazolam. The product's dosage form is tablet and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0009-0090-01 100 tablet in 1 bottle , 0009-0090-04 500 tablet in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Xanax?

Alprazolam is used to treat anxiety and panic disorders. It belongs to a class of medications called benzodiazepines which act on the brain and nerves (central nervous system) to produce a calming effect. It works by enhancing the effects of a certain natural chemical in the body (GABA).

What are Xanax Active Ingredients?

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.
  • ALPRAZOLAM 1 mg/1 - A triazolobenzodiazepine compound with antianxiety and sedative-hypnotic actions, that is efficacious in the treatment of PANIC DISORDERS, with or without AGORAPHOBIA, and in generalized ANXIETY DISORDERS. (From AMA Drug Evaluations Annual, 1994, p238)

Which are Xanax UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Xanax 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:

Which are the Pharmacologic Classes for Xanax?

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.

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Patient Education

Alprazolam


Alprazolam is used to treat anxiety disorders and panic disorder (sudden, unexpected attacks of extreme fear and worry about these attacks). Alprazolam is in a class of medications called benzodiazepines. It works by decreasing abnormal excitement in the brain.
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Product Label

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