NDC Package 69844-049-01 Tramadol Hcl And Acetaminophen

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Package Information
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Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:

69844-049-01

Package Description:

100 TABLET, FILM COATED in 1 BOTTLE

Product Code:

69844-049

Proprietary Name:

Tramadol Hcl And Acetaminophen

Usage Information:

Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseTramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less.Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:Have not been tolerated, or are not expected to be tolerated,Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

11-Digit NDC Billing Format:

69844004901

NDC to RxNorm Crosswalk:

RxCUI: 836395 - traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet
RxCUI: 836395 - acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet
RxCUI: 836395 - APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet

Labeler Name:

Graviti Pharmaceuticals Private Limited

Sample Package:

FDA Application Number:

ANDA076914

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

04-06-2020

Listing Expiration Date:

12-31-2021

Exclude Flag:

Code Structure:

69844 - Graviti Pharmaceuticals Private Limited
- 69844-049 - Tramadol Hcl And Acetaminophen
  - 69844-049-01 - 100 TABLET, FILM COATED in 1 BOTTLE

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 Code	Package Description
69844-049-02	500 TABLET, FILM COATED in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 69844-049-01?

The NDC Packaged Code 69844-049-01 is assigned to a package of 100 tablet, film coated in 1 bottle of Tramadol Hcl And Acetaminophen, labeled by Graviti Pharmaceuticals Private Limited. The product's dosage form is and is administered via form.

Is NDC 69844-049 included in the NDC Directory?

No, Tramadol Hcl And Acetaminophen with product code 69844-049 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Graviti Pharmaceuticals Private Limited on April 06, 2020 and its listing in the NDC Directory is set to expire on December 31, 2021 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 69844-049-01?

The 11-digit format is 69844004901. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	69844-049-01	5-4-2	69844-0049-01

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