NDC Package 53489-648-05 Temazepam

Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

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:
53489-648-05
Package Description:
500 CAPSULE in 1 BOTTLE, PLASTIC
Product Code:
Proprietary Name:
Temazepam
Non-Proprietary Name:
Temazepam
Substance Name:
Temazepam
Usage Information:
This medication is used to treat a certain sleep problem (insomnia). It may help you fall asleep faster, stay asleep longer, and lessen how often you wake up during the night, so you can get a better night's rest. Temazepam belongs to a class of drugs called benzodiazepines. It acts on your brain to produce a calming effect. Use of this medication is usually limited to short treatment periods of 1 to 2 weeks or less. If your insomnia continues for a longer time, talk to your doctor to see if you need other treatment.
11-Digit NDC Billing Format:
53489064805
NDC to RxNorm Crosswalk:
  • RxCUI: 198241 - temazepam 15 MG Oral Capsule
  • RxCUI: 198242 - temazepam 30 MG Oral Capsule
  • RxCUI: 198243 - temazepam 7.5 MG Oral Capsule
  • RxCUI: 485489 - temazepam 22.5 MG Oral Capsule
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sun Pharmaceutical Industries, Inc.
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    DEA Schedule:
    Schedule IV (CIV) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA078581
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-09-2009
    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
    53489-648-01100 CAPSULE in 1 BOTTLE, PLASTIC
    53489-648-03250 CAPSULE in 1 BOTTLE, PLASTIC
    53489-648-0660 CAPSULE in 1 BOTTLE, PLASTIC
    53489-648-0730 CAPSULE in 1 BOTTLE, PLASTIC
    53489-648-101000 CAPSULE in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53489-648-05?

    The NDC Packaged Code 53489-648-05 is assigned to a package of 500 capsule in 1 bottle, plastic of Temazepam, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. The product's dosage form is capsule and is administered via oral form.

    Is NDC 53489-648 included in the NDC Directory?

    Yes, Temazepam with product code 53489-648 is active and included in the NDC Directory. The product was first marketed by Sun Pharmaceutical Industries, Inc. on September 09, 2009 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 53489-648-05?

    The 11-digit format is 53489064805. 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
    5-3-253489-648-055-4-253489-0648-05