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  5. NDC Package Code: 68071-3644-3 Tramadol Hydrochloride

NDC Package 68071-3644-3 Tramadol Hydrochloride

Tablet 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:
68071-3644-3
Package Description:
30 TABLET in 1 PACKAGE
Product Code:
68071-3644
Proprietary Name:
Tramadol Hydrochloride
Non-Proprietary Name:
Tramadol Hydrochloride
Substance Name:
Tramadol Hydrochloride
Usage Information:
Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration ( 5.1), reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products):  Have not been tolerated, or are not expected to be tolerated, (1) Have not provided adequate analgesia, or are not expected to provide adequate analgesia (1)Tramadol hydrochloride tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
11-Digit NDC Billing Format:
68071364403
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Nucare Pharmaceuticals, Inc.
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
TRAMADOL HYDROCHLORIDE 50 mg/1
Pharmacologic Class(es):
DEA Schedule:
Schedule IV (CIV) Substances
Sample Package:
No
FDA Application Number:
ANDA202075
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
03-01-2018
Listing Expiration Date:
12-31-2025
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
68071-3644-440 TABLET in 1 PACKAGE
68071-3644-515 TABLET in 1 PACKAGE
68071-3644-660 TABLET in 1 PACKAGE
68071-3644-990 TABLET in 1 PACKAGE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 68071-3644-3?

The NDC Packaged Code 68071-3644-3 is assigned to a package of 30 tablet in 1 package of Tramadol Hydrochloride, a human prescription drug labeled by Nucare Pharmaceuticals, Inc.. The product's dosage form is tablet and is administered via oral form.

Is NDC 68071-3644 included in the NDC Directory?

Yes, Tramadol Hydrochloride with product code 68071-3644 is active and included in the NDC Directory. The product was first marketed by Nucare Pharmaceuticals, Inc. on March 01, 2018 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 68071-3644-3?

The 11-digit format is 68071364403. 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 5-4-1 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
5-4-168071-3644-35-4-268071-3644-03