Bupropion

BUPROPION — bupropion hydrochloride tablet, extended release
Zydus Lifesciences Limited

Manufactured by:

Cadila Healthcare Ltd.

India.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-780-05

Bupropion Hydrochloride Extended-release Tablets USP (XL), 300 mg

500 Tablets

Rx only

NDC 65841-836-05

Bupropion Hydrochloride Extended-release Tablets USP (XL), 150 mg

500 Tablets

Rx only

BUPROPION bupropion tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-780 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUPROPION HYDROCHLORIDE (BUPROPION) BUPROPION HYDROCHLORIDE 300 mg

Inactive Ingredients Ingredient Name Strength HYPROMELLOSES MAGNESIUM STEARATE METHACRYLIC ACID POLYETHYLENE GLYCOL, UNSPECIFIED TRIETHYL CITRATE POVIDONE ETHYLCELLULOSES SILICON DIOXIDE BUTYL ALCOHOL FERROSOFERRIC OXIDE ISOPROPYL ALCOHOL PROPYLENE GLYCOL SHELLAC AMMONIA

Product Characteristics Color YELLOW (CREAMY WHITE TO PALE YELLOW) Score no score Shape ROUND (ROUND) Size 9mm Flavor Imprint Code 354 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65841-780-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:65841-780-16 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None 3 NDC:65841-780-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None 4 NDC:65841-780-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201567 02/15/2014

BUPROPION bupropion tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-836 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUPROPION HYDROCHLORIDE (BUPROPION) BUPROPION HYDROCHLORIDE 150 mg

Inactive Ingredients Ingredient Name Strength HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED METHACRYLIC ACID TRIETHYL CITRATE POVIDONE ETHYLCELLULOSES SILICON DIOXIDE BUTYL ALCOHOL FERROSOFERRIC OXIDE ISOPROPYL ALCOHOL PROPYLENE GLYCOL SHELLAC AMMONIA

Product Characteristics Color YELLOW (CREAMY WHITE TO PALE YELLOW) Score no score Shape ROUND (ROUND) Size 8mm Flavor Imprint Code 353 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65841-836-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:65841-836-16 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None 3 NDC:65841-836-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None 4 NDC:65841-836-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201567 08/02/2018

Labeler — Zydus Lifesciences Limited (918596198)

Registrant — Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Operations
Zydus Lifesciences Limited		918596198	ANALYSIS (65841-780), ANALYSIS (65841-836), MANUFACTURE (65841-780), MANUFACTURE (65841-836)

Revised: 08/2022 Zydus Lifesciences Limited