NDC Code(s) : 42571-241-01, 42571-242-01
Packager : Micro Labs Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BUPROPION HYDROCHLORIDEBupropion Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-241
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O)
(BUPROPION - UNII:01ZG3TPX31) 		BUPROPION HYDROCHLORIDE75 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CYSTEINE HYDROCHLORIDE(UNII: ZT934N0X4W)
HYPROMELLOSES(UNII: 3NXW29V3WO)
STEARIC ACID(UNII: 4ELV7Z65AP)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
TRIACETIN(UNII: XHX3C3X673)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
Product Characteristics
Color yellow Score no score
Shape ROUND (biconvex) Size 11 mm
Flavor Imprint Code C43
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42571-241-01100 in 1 BOTTLE Type 0: Not a Combination Product07/01/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207403 07/01/2020
BUPROPION HYDROCHLORIDEBupropion Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-242
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O)
(BUPROPION - UNII:01ZG3TPX31) 		BUPROPION HYDROCHLORIDE100 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CYSTEINE HYDROCHLORIDE(UNII: ZT934N0X4W)
HYPROMELLOSES(UNII: 3NXW29V3WO)
STEARIC ACID(UNII: 4ELV7Z65AP)
TRIACETIN(UNII: XHX3C3X673)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
Product Characteristics
Color red Score no score
Shape ROUND (biconvex) Size 12 mm
Flavor Imprint Code C44
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42571-242-01100 in 1 BOTTLE Type 0: Not a Combination Product07/01/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207403 07/01/2020

LABELER - Micro Labs Limited(862174955)

Establishment
Name Address ID/FEI Business Operations
Micro Labs Limited 915793658 analysis(42571-241, 42571-242), label(42571-241, 42571-242), manufacture(42571-241, 42571-242), pack(42571-241, 42571-242)

PRINCIPAL DISPLAY PANEL


NDC 42571-241-01
Three Times Daily (After Initial Titration)
Bupropion Hydrochloride Tablets, USP
75 mg
PHARMACIST: Dispense the enclosed Medication Guide to each patient.
WARNING: Do not use with other medicines that contain bupropion hydrochloride.
Federal Law requires dispensing of Bupropion Hydrochloride Tablets USP with the Medication Guide under this label.
Rx Only
100 Tablets
MICRO LABS LIMITED


bupropion-stra.jpg


NDC 42571-242-01
Three Times Daily (After Initial Titration)
Bupropion Hydrochloride Tablets, USP
100 mg
PHARMACIST: Dispense the enclosed Medication Guide to each patient.
WARNING: Do not use with other medicines that contain bupropion hydrochloride.
Federal Law requires dispensing of Bupropion Hydrochloride Tablets USP with the Medication Guide under this label.
Rx Only
100 Tablets
MICRO LABS LIMITED





bupropion-stra.jpg