NDC Package 70436-058-05 Bupropion Hydrochloride SR

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:
70436-058-05
Package Description:
60 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
Proprietary Name:
Bupropion Hydrochloride SR
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:
70436005805
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
  • RxCUI: 993518 - buPROPion HCl 150 MG 12HR Extended Release Oral Tablet
  • RxCUI: 993518 - 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Slate Run Pharmaceuticals, Llc
    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):
    Sample Package:
    No
    FDA Application Number:
    ANDA211347
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-02-2020
    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
    70436-058-01100 TABLET, EXTENDED RELEASE in 1 BOTTLE
    70436-058-02500 TABLET, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70436-058-05?

    The NDC Packaged Code 70436-058-05 is assigned to a package of 60 tablet, extended release in 1 bottle of Bupropion Hydrochloride SR, a human prescription drug labeled by Slate Run Pharmaceuticals, Llc. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 70436-058 included in the NDC Directory?

    Yes, Bupropion Hydrochloride SR with product code 70436-058 is active and included in the NDC Directory. The product was first marketed by Slate Run Pharmaceuticals, Llc on November 02, 2020 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 70436-058-05?

    The 11-digit format is 70436005805. 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
    5-3-270436-058-055-4-270436-0058-05