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

Bupropion hydrochloride extended-release tablets, USP (XL)
(click image for full-size original)

NDC 65841-836-05

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

500 Tablets

Rx only

label
(click image for full-size original)
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

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