Zolpidem Tartrate Tablet
NDC 13668-008
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Zolpidem Tartrate is a ANDA-approved product labeled by Torrent Pharmaceuticals Limited. Zolpidem is used to treat a certain sleep problem (insomnia) in adults. It is supplied as a red tablet for oral administration. This product entry covers the primary NDC 13668-008 and 6 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
13668-008
Proprietary Name:
Zolpidem Tartrate
Non-Proprietary Name: [1]
Zolpidem Tartrate
Substance Name: [2]
Zolpidem Tartrate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Tablet
- A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
13668
Product Label ID:
FDA Application Number: [6]
ANDA077903
DEA Schedule: [7]
Schedule IV (CIV) Substances
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
09-05-2007
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Product Characteristics
Color(s):
RED (C48326 - RED)
YELLOW (C48330 - PEACH-YELLOW)
YELLOW (C48330 - PEACH-YELLOW)
Shape:
CAPSULE (C48336)
Size(s):
10 MM
Imprint(s):
5MG
10MG
Score:
1
Code Structure Chart
Product Details
What is NDC 13668-008?
The NDC code 13668-008 is assigned by the FDA to the product Zolpidem Tartrate. This pharmaceutical product is labeled by Torrent Pharmaceuticals Limited and is currently categorized as listed product. The medication is a tablet administered via oral route. In terms of distribution, this product is available in 6 different package configurations. 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?
Zolpidem is used to treat a certain sleep problem (insomnia) in adults. If you have trouble falling asleep, it helps you fall asleep faster, so you can get a better night's rest. Zolpidem belongs to a class of drugs called sedative-hypnotics. It acts on your brain to produce a calming effect. This medication is usually limited to short treatment periods of 1 to 2 weeks or less.
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.
- ZOLPIDEM TARTRATE 10 mg/1 - An imidazopyridine derivative and short-acting GABA-A receptor agonist that is used for the treatment of INSOMNIA.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- ZOLPIDEM TARTRATE (UNII: WY6W63843K)
- ZOLPIDEM (UNII: 7K383OQI23) (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:
- FERRIC OXIDE RED (UNII: 1K09F3G675)
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: 854873 - zolpidem tartrate 10 MG Oral Tablet
- RxCUI: 854876 - zolpidem tartrate 5 MG 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
Zolpidem
Zolpidem is used to treat insomnia (difficulty falling asleep or staying asleep). Zolpidem belongs to a class of medications called sedative-hypnotics. It works by slowing activity in the brain to allow sleep.
[Learn More]
Montelukast
Montelukast is used to prevent wheezing, difficulty breathing, chest tightness, and coughing caused by asthma in adults and children 12 months of age and older. Montelukast is also used to prevent bronchospasm (breathing difficulties) during exercise in adults and children 6 years of age and older. Montelukast is also used to treat the symptoms of seasonal (occurs only at certain times of the year), allergic rhinitis (a condition associated with sneezing and stuffy, runny or itchy nose) in adults and children 2 years of age and older, and perennial (occurs all year round) allergic rhinitis in adults and children 6 months of age and older. Montelukast should be used to treat seasonal or perennial allergic rhinitis only in adults and children who cannot be treated with other medications. Montelukast is in a class of medications called leukotriene receptor antagonists (LTRAs). It works by blocking the action of substances in the body that cause the symptoms of asthma and allergic rhinitis.
[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 DEA Schedule? This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.
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".
