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  5. NDC Package Code: 47335-308-13 Zolpidem Tartrate

NDC Package 47335-308-13 Zolpidem Tartrate

Tablet, Film Coated, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
47335-308-13
Package Description:
500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code:
47335-308
Proprietary Name:
Zolpidem Tartrate
Non-Proprietary Name:
Zolpidem Tartrate
Substance Name:
Zolpidem Tartrate
Usage Information:
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.
11-Digit NDC Billing Format:
47335030813
NDC to RxNorm Crosswalk:
  • RxCUI: 854880 - zolpidem tartrate 12.5 MG Extended Release Oral Tablet
  • RxCUI: 854894 - zolpidem tartrate 6.25 MG Extended Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sun Pharmaceutical Industries, Inc.
    Dosage Form:
    Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ZOLPIDEM TARTRATE 12.5 mg/1
    • Pharmacologic Class(es):
  • Central Nervous System Depression - [PE] (Physiologic Effect)
  • GABA A Agonists - [MoA] (Mechanism of Action)
  • Pyridines - [CS]
  • gamma-Aminobutyric Acid-ergic Agonist - [EPC] (Established Pharmacologic Class)
    • DEA Schedule:
    Schedule IV (CIV) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA204170
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-15-2017
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    47335-308-88100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 47335-308-13?

    The NDC Packaged Code 47335-308-13 is assigned to a package of 500 tablet, film coated, extended release in 1 bottle of Zolpidem Tartrate, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

    Is NDC 47335-308 included in the NDC Directory?

    Yes, Zolpidem Tartrate with product code 47335-308 is active and included in the NDC Directory. The product was first marketed by Sun Pharmaceutical Industries, Inc. on May 15, 2017 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 47335-308-13?

    The 11-digit format is 47335030813. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-247335-308-135-4-247335-0308-13