87063-174 NDC - ALPRAZOLAM

Drug Information

Product NDC: 87063-174
Proprietary Name: Alprazolam
Non Proprietary Name: Alprazolam
Active Ingredient(s): 2 mg/1 ALPRAZOLAM
Administration Route(s): ORAL
Dosage Form(s): TABLET
Pharmacy Class(es): Benzodiazepine [EPC]; Benzodiazepines [CS]

Labeler Information

Field Name	Field Value
Labeler Name:	ASCLEMED USA INC.
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	ANDA203346
Marketing Category:	ANDA
Start Marketing Date:	7/31/2015
DEA Schedule:	CIV

Package Information

No.	Package Code	Package Description	Billing Unit
1	87063-174-01	100 TABLET in 1 BOTTLE (87063-174-01)
2	87063-174-30	30 TABLET in 1 BOTTLE (87063-174-30)
3	87063-174-60	60 TABLET in 1 BOTTLE (87063-174-60)
4	87063-174-90	90 TABLET in 1 BOTTLE (87063-174-90)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	87063-174	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	HUMAN PRESCRIPTION DRUG	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAME	Alprazolam	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.
NON PROPRIETARY NAME	Alprazolam	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	TABLET	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.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	7/31/2015	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	ANDA	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.
APPLICATION NUMBER	ANDA203346	This is the date that the labeler indicates was the start of its marketing of the drug product.
LABELER NAME	ASCLEMED USA INC.	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.
SUBSTANCE NAME	ALPRAZOLAM	Name of Company corresponding to the labeler code segment of the Product NDC.
ACTIVE NUMERATOR STRENGTH	2
ACTIVE INGRED UNIT	mg/1	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.
PHARM CLASSES	Benzodiazepine [EPC], Benzodiazepines [CS]
DEA SCHEDULE	CIV	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.

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This page was last updated on: 5/7/2026

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