NDC 70518-2865 Zolpidem Tartrate
Tablet Oral

Product Information
Product Packages
Product Characteristics
What is NDC 70518-2865?
Zolpidem Tartrate Uses
Active Ingredients
Active Ingredients UNII Codes
Inactive Ingredients UNII Codes
NDC to RxNorm Crosswalk
Pharmacologic Classes
Patient Education

Product Information

NDC Product Code	70518-2865
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.	Zolpidem Tartrate
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.	Zolpidem Tartrate
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.	Zolpidem Tartrate
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 Status	ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form	Tablet - 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.	Remedyrepack Inc.
Labeler Code	70518
SPL SET ID:	00e72f41-4347-4199-843f-69de9cccd75a
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.	ANDA077903
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.	ANDA - A product marketed under an approved Abbreviated 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.	09-01-2020
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.	12-31-2023
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	70518 - Remedyrepack Inc. 70518-2865 - Zolpidem Tartrate 70518-2865-0 70518-2865-2

Product Characteristics

Color(s)	YELLOW (C48330 - PEACH-YELLOW)
Shape	CAPSULE (C48336)
Size(s)	10 MM
Imprint(s)	10MG
Score	1

Product Packages

NDC Code 70518-2865-0

Package Description: 100 POUCH in 1 BOX / 1 TABLET in 1 POUCH (70518-2865-1)

NDC Code 70518-2865-2

Package Description: 30 TABLET in 1 BLISTER PACK

Product Details

What is NDC 70518-2865?

The NDC code 70518-2865 is assigned by the FDA to the product Zolpidem Tartrate which is a human prescription drug product labeled by Remedyrepack Inc.. The product's dosage form is tablet and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 70518-2865-0 100 pouch in 1 box / 1 tablet in 1 pouch (70518-2865-1), 70518-2865-2 30 tablet in 1 blister pack . 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 Zolpidem Tartrate?

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 Zolpidem Tartrate 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.

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 Zolpidem Tartrate UNII Codes?

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

ZOLPIDEM TARTRATE (UNII: WY6W63843K)
ZOLPIDEM (UNII: 7K383OQI23) (Active Moiety)

Which are Zolpidem Tartrate 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:

FERRIC OXIDE RED (UNII: 1K09F3G675)

What is the NDC to RxNorm Crosswalk for Zolpidem Tartrate?

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 code indicates a single concept unique identifier (RXCUI) is associated with this product:

RxCUI: 854873 - zolpidem tartrate 10 MG Oral Tablet

Which are the Pharmacologic Classes for Zolpidem Tartrate?

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 disclaimer below.

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]