NDC Package 47335-859-08 Tramadol Hydrochloride

Tablet, Extended Release 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:
47335-859-08
Package Description:
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
Proprietary Name:
Tramadol Hydrochloride
Non-Proprietary Name:
Tramadol Hydrochloride
Substance Name:
Tramadol Hydrochloride
Usage Information:
Tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.
11-Digit NDC Billing Format:
47335085908
NDC to RxNorm Crosswalk:
  • RxCUI: 833709 - traMADol HCl 100 MG 24HR Extended Release Oral Tablet
  • RxCUI: 833709 - 24 HR tramadol hydrochloride 100 MG Extended Release Oral Tablet
  • RxCUI: 833709 - tramadol hydrochloride 100 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 833711 - traMADol HCl 200 MG 24HR Extended Release Oral Tablet
  • RxCUI: 833711 - 24 HR tramadol hydrochloride 200 MG Extended Release Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sun Pharmaceutical Industries, Inc.
    Dosage Form:
    Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
    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:
    ANDA201384
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-12-2011
    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
    47335-859-181000 TABLET, EXTENDED RELEASE in 1 BOTTLE
    47335-859-8330 TABLET, EXTENDED RELEASE in 1 BOTTLE
    47335-859-88100 TABLET, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 47335-859-08?

    The NDC Packaged Code 47335-859-08 is assigned to a package of 100 tablet, extended release in 1 bottle of Tramadol Hydrochloride, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 47335-859 included in the NDC Directory?

    Yes, Tramadol Hydrochloride with product code 47335-859 is active and included in the NDC Directory. The product was first marketed by Sun Pharmaceutical Industries, Inc. on December 12, 2011 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 47335-859-08?

    The 11-digit format is 47335085908. 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
    5-3-247335-859-085-4-247335-0859-08