BUPROPION- bupropion tablet, extended release 
Zydus Lifesciences Limited

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BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL)

Manufactured by:

Cadila Healthcare Ltd.

India.

SPL MEDGUIDE

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)

NDC 65841-836-05

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

500 Tablets

Rx only

label
BUPROPION 
bupropion tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-780
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31) BUPROPION HYDROCHLORIDE300 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
POVIDONE (UNII: FZ989GH94E)  
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
AMMONIA (UNII: 5138Q19F1X)  
Product Characteristics
ColorYELLOW (CREAMY WHITE TO PALE YELLOW) Scoreno score
ShapeROUND (ROUND) Size9mm
FlavorImprint Code 354
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-780-0630 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
2NDC:65841-780-1690 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
3NDC:65841-780-05500 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
4NDC:65841-780-101000 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20156702/15/2014
BUPROPION 
bupropion tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-836
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31) BUPROPION HYDROCHLORIDE150 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
POVIDONE (UNII: FZ989GH94E)  
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
AMMONIA (UNII: 5138Q19F1X)  
Product Characteristics
ColorYELLOW (CREAMY WHITE TO PALE YELLOW) Scoreno score
ShapeROUND (ROUND) Size8mm
FlavorImprint Code 353
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-836-0630 in 1 BOTTLE; Type 0: Not a Combination Product08/02/2018
2NDC:65841-836-1690 in 1 BOTTLE; Type 0: Not a Combination Product08/02/2018
3NDC:65841-836-05500 in 1 BOTTLE; Type 0: Not a Combination Product08/02/2018
4NDC:65841-836-101000 in 1 BOTTLE; Type 0: Not a Combination Product08/02/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20156708/02/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-780, 65841-836) , MANUFACTURE(65841-780, 65841-836)

Revised: 11/2024
Document Id: 6c831525-a7c2-4ef1-b1b9-c7e8cb807ded
Set id: 78d34aad-9d4f-48c4-91eb-536e31c6b6c9
Version: 11
Effective Time: 20241126
 
Zydus Lifesciences Limited