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  5. NDC Package Code: 0115-6811-02 Bupropion Hydrochloride

NDC Package 0115-6811-02 Bupropion Hydrochloride

Tablet, Film Coated, Extended Release 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:
0115-6811-02
Package Description:
500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code:
0115-6811
Proprietary Name:
Bupropion Hydrochloride
Non-Proprietary Name:
Bupropion Hydrochloride
Substance 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) is 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:
00115681102
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
500 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 993541 - buPROPion HCl 150 MG 24HR Extended Release Oral Tablet
  • RxCUI: 993541 - 24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet
  • RxCUI: 993541 - bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amneal Pharmaceuticals Of New York Llc
    Dosage Form:
    Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • BUPROPION HYDROCHLORIDE 150 mg/1
    • Pharmacologic Class(es):
  • Aminoketone - [EPC] (Established Pharmacologic Class)
  • Dopamine Uptake Inhibitors - [MoA] (Mechanism of Action)
  • Increased Dopamine Activity - [PE] (Physiologic Effect)
  • Increased Norepinephrine Activity - [PE] (Physiologic Effect)
  • Norepinephrine Uptake Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA077415
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-01-2009
    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
    0115-6811-0830 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
    0115-6811-1090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0115-6811-02?

    The NDC Packaged Code 0115-6811-02 is assigned to a package of 500 tablet, film coated, extended release in 1 bottle of Bupropion Hydrochloride, a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

    Is NDC 0115-6811 included in the NDC Directory?

    Yes, Bupropion Hydrochloride with product code 0115-6811 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Of New York Llc on May 01, 2009 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 NDC billing unit for package 0115-6811-02?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 500.

    What is the 11-digit format for NDC 0115-6811-02?

    The 11-digit format is 00115681102. 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 4-4-2 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
    4-4-20115-6811-025-4-200115-6811-02