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  5. NDC Package Code: 69844-010-02 Bupropion Hydrochloride

NDC Package 69844-010-02 Bupropion Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:
69844-010-02
Package Description:
90 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
69844-010
Proprietary Name:
Bupropion Hydrochloride
Usage Information:
Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with seizure disorder.Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with bupropion hydrochloride extended-release tablets (XL) [see Warnings and Precautions (5.3)] .Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Warnings and Precautions (5.3) and Drug Interactions (7.3)] .The use of MAOIs (intended to treat psychiatric disorders) concomitantly with bupropion hydrochloride extended-release tablets (XL) or within 14 days of discontinuing treatment with bupropion hydrochloride extended-release tablets (XL) are contraindicated. There is an increased risk of hypertensive reactions when bupropion hydrochloride extended-release tablets (XL) are used concomitantly with MAOIs. The use of bupropion hydrochloride extended-release tablets (XL) within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting bupropion hydrochloride extended-release tablets (XL) in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated [see Dosage and Administration (2.9), Warnings and Precautions (5.4) and Drug Interactions (7.6)] .Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with known hypersensitivity to bupropion or other ingredients of bupropion hydrochloride extended-release tablets (XL). Anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported [see Warnings and Precautions (5.8)].
11-Digit NDC Billing Format:
69844001002
Labeler Name:
Graviti Pharmaceuticals Private Limited
Sample Package:
No
FDA Application Number:
ANDA211020
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
01-28-2019
End Marketing Date:
05-24-2021
Listing Expiration Date:
05-24-2021
Exclude Flag:
D
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
69844-010-0130 TABLET, EXTENDED RELEASE in 1 BOTTLE
69844-010-0130 TABLET in 1 BOTTLE
69844-010-031000 TABLET, EXTENDED RELEASE in 1 BOTTLE
69844-010-031000 TABLET in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 69844-010-02?

The NDC Packaged Code 69844-010-02 is assigned to a package of 90 tablet, extended release in 1 bottle of Bupropion Hydrochloride, labeled by Graviti Pharmaceuticals Private Limited. The product's dosage form is and is administered via form.

Is NDC 69844-010 included in the NDC Directory?

No, Bupropion Hydrochloride with product code 69844-010 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Graviti Pharmaceuticals Private Limited on January 28, 2019 and its listing in the NDC Directory is set to expire on May 24, 2021 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 69844-010-02?

The 11-digit format is 69844001002. 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
5-3-269844-010-025-4-269844-0010-02