Drug Information

  • Product NDC: 0024-5521
  • Proprietary Name: Ambien
  • Non Proprietary Name: zolpidem tartrate
  • Active Ingredient(s): 12.5 mg/1 ZOLPIDEM TARTRATE
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET, COATED
  • Pharmacy Class(es): Central Nervous System Depression [PE]; GABA A Agonists [MoA]; Pyridines [CS]; gamma-Aminobutyric Acid-ergic Agonist [EPC]/li>

Labeler Information

Field Name Field Value
Labeler Name: sanofi-aventis U.S. LLC
FDA Application Number: NDA021774
Marketing Category: NDA
Start Marketing Date:9/19/2005
DEA Schedule:CIV

Package Information

No. Package Code Package Description Billing Unit
10024-5521-31100 TABLET, COATED in 1 BOTTLE (0024-5521-31)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0024-5521The 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 NAMEHUMAN PRESCRIPTION DRUGIndicates 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.
PROPRIETARY NAMEAmbienThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXCRA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAMEzolpidem tartrateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, COATEDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE9/19/2005This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct 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 NUMBERNDA021774This 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.
LABELER NAMEsanofi-aventis U.S. LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEZOLPIDEM TARTRATEAn 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.
PHARM CLASSESCentral Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC] 
DEA SCHEDULECIVThis is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

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This page was last updated on: 4/12/2024