Bupropion Hydrochloride SR (Page 9 of 9)

Package/Label Display Panel

NDC 43598-751-60

Twice-A-Day (After Initial Titration)

buPROPion HCL Extended-Release Tablets, USP (SR)

100 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

WARNING: Do not use in combination with ZYBAN ® or other medicines that contain bupropion hydrochloride.

Rx Only

60 Tablets

Dr.Reddy’s

bupropion-label1
(click image for full-size original)

NDC 43598-751-01

Twice-A-Day (After Initial Titration)

buPROPion HCL Extended-Release Tablets, USP (SR)

100 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

WARNING: Do not use in combination with ZYBAN ® or any other medicines that contain bupropion hydrochloride.

Rx Only

100 Tablets

Dr.Reddy’s

bupropion-label2
(click image for full-size original)

NDC 43598-751-05

Twice-A-Day (After Initial Titration)

buPROPion HCL Extended-Release Tablets, USP (SR)

100 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

WARNING: Do not use in combination with ZYBAN ® or any other medicines that contain bupropion hydrochloride.

Rx Only

500 Tablets

Dr.Reddy’s

bupropion-label3
(click image for full-size original)

NDC 43598-752-60

Twice-A-Day (After Initial Titration)

buPROPion HCL Extended-Release Tablets, USP (SR)

150 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

WARNING: Do not use in combination with ZYBAN ® or any other medicines that contain bupropion hydrochloride.

Rx Only

60 Tablets

Dr.Reddy’s

bupropion-label4
(click image for full-size original)

NDC 43598-752-01

Twice-A-Day (After Initial Titration)

buPROPion HCL Extended-Release Tablets, USP (SR)

150 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

WARNING: Do not use in combination with ZYBAN ® or any other medicines that contain bupropion hydrochloride.

Rx Only

100 Tablets

Dr.Reddy’s

bupropion-label5
(click image for full-size original)

NDC 43598-752-05

Twice-A-Day (After Initial Titration)

buPROPion HCL Extended-Release Tablets, USP (SR)

150 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

WARNING: Do not use in combination with ZYBAN ® or any other medicines that contain bupropion hydrochloride.

Rx Only

500 Tablets

Dr.Reddy’s

bupropion-label6
(click image for full-size original)

NDC 43598-753-60

Twice-A-Day (After Initial Titration)

buPROPion HCL Extended-Release Tablets, USP (SR)

200 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

WARNING: Do not use in combination with ZYBAN ® or any other medicines that contain bupropion hydrochloride.

Rx Only

60 Tablets

Dr.Reddy’s

bupropion-label7
(click image for full-size original)
BUPROPION HYDROCHLORIDE SR bupropion hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-751
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE (BUPROPION) BUPROPION HYDROCHLORIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
COPOVIDONE
CYSTEINE HYDROCHLORIDE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TITANIUM DIOXIDE
FD&C BLUE NO. 1
DEXTROSE, UNSPECIFIED FORM
ALCOHOL
ACACIA
PROPYLENE GLYCOL
SILICON DIOXIDE
Product Characteristics
Color blue Score no score
Shape ROUND (biconvex) Size 9mm
Flavor Imprint Code SG;174
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-751-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:43598-751-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
3 NDC:43598-751-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205794 05/15/2018
BUPROPION HYDROCHLORIDE SR bupropion hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-752
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
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FD&C RED NO. 40
DEXTROSE, UNSPECIFIED FORM
ALCOHOL
ACACIA
PROPYLENE GLYCOL
SILICON DIOXIDE
COPOVIDONE
CYSTEINE HYDROCHLORIDE
HYPROMELLOSES
MAGNESIUM STEARATE
Product Characteristics
Color purple Score no score
Shape ROUND (biconvex) Size 11mm
Flavor Imprint Code SG;175
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-752-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:43598-752-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
3 NDC:43598-752-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205794 05/15/2018
BUPROPION HYDROCHLORIDE SR bupropion hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-753
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE (BUPROPION) BUPROPION HYDROCHLORIDE 200 mg
Inactive Ingredients
Ingredient Name Strength
COPOVIDONE
CYSTEINE HYDROCHLORIDE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TITANIUM DIOXIDE
FD&C RED NO. 40
DEXTROSE, UNSPECIFIED FORM
ALCOHOL
ACACIA
PROPYLENE GLYCOL
SILICON DIOXIDE
Product Characteristics
Color pink Score no score
Shape ROUND (biconvex) Size 12mm
Flavor Imprint Code SG;176
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-753-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205794 05/15/2018
Labeler — Dr. Reddy’s Laboratories Inc. (802315887)
Establishment
Name Address ID/FEI Operations
ScieGen Pharmaceuticals, Inc. 079391286 analysis (43598-751), analysis (43598-752), analysis (43598-753), manufacture (43598-751), manufacture (43598-752), manufacture (43598-753)

Revised: 03/2023 Dr. Reddy’s Laboratories Inc.

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