NDC Package 71335-0019-5 Bupropion Hydrochloride

Tablet, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

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:
71335-0019-5
Package Description:
28 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
Proprietary Name:
Bupropion Hydrochloride
Non-Proprietary Name:
Bupropion Hydrochloride
Substance Name:
Bupropion Hydrochloride
Usage Information:
Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)].The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].
11-Digit NDC Billing Format:
71335001905
NDC to RxNorm Crosswalk:
  • RxCUI: 993503 - buPROPion HCl 100 MG 12HR Extended Release Oral Tablet
  • RxCUI: 993503 - 12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet
  • RxCUI: 993503 - bupropion HCl 100 MG 12 HR Extended Release Oral Tablet
Product Type:
Human Prescription Drug
Labeler Name:
Bryant Ranch Prepack
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.
Sample Package:
No
FDA Application Number:
ANDA075932
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
11-25-2003
End Marketing Date:
07-31-2025
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
71335-0019-160 TABLET, EXTENDED RELEASE in 1 BOTTLE
71335-0019-290 TABLET, EXTENDED RELEASE in 1 BOTTLE
71335-0019-330 TABLET, EXTENDED RELEASE in 1 BOTTLE
71335-0019-445 TABLET, EXTENDED RELEASE in 1 BOTTLE
71335-0019-6120 TABLET, EXTENDED RELEASE in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 71335-0019-5?

The NDC Packaged Code 71335-0019-5 is assigned to a package of 28 tablet, extended release in 1 bottle of Bupropion Hydrochloride, a human prescription drug labeled by Bryant Ranch Prepack. The product's dosage form is tablet, extended release and is administered via oral form.

Is NDC 71335-0019 included in the NDC Directory?

Yes, Bupropion Hydrochloride with product code 71335-0019 is active and included in the NDC Directory. The product was first marketed by Bryant Ranch Prepack on November 25, 2003.

What is the 11-digit format for NDC 71335-0019-5?

The 11-digit format is 71335001905. 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
5-4-171335-0019-55-4-271335-0019-05