BUPROPION HYDROCHLORIDE (SR) (Page 10 of 10)

Principal Display Panel

NDC 69097-877-03 Rx Only

Twice-A-Day (After Initial Titration)

buPROPion HCL
Extended-release
Tablets, USP (SR)

100 mg

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

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

60 Tablets

Cipla

bupropion-100mg
(click image for full-size original)

NDC 69097-878-03 Rx Only

Twice-A-Day (After Initial Titration)

buPROPion HCL
Extended-release
Tablets, USP (SR)

150 mg

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

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

60 Tablets

Cipla

bupropion-150mg
(click image for full-size original)

NDC 69097-879-03 Rx Only

Twice-A-Day (After Initial Titration)

buPROPion HCL
Extended-release
Tablets, USP (SR)

200 mg

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

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

60 Tablets

Cipla

bupropion-200mg
(click image for full-size original)
BUPROPION HYDROCHLORIDE (SR) bupropion hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-877
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
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
HYDROCHLORIC ACID
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
FD&C BLUE NO. 1
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code IG;484
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69097-877-02 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:69097-877-03 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:69097-877-07 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:69097-877-12 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206674 07/25/2016
BUPROPION HYDROCHLORIDE (SR) bupropion hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-878
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
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
HYDROCHLORIC ACID
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
FD&C BLUE NO. 2
FD&C RED NO. 40
Product Characteristics
Color purple Score no score
Shape ROUND Size 11mm
Flavor Imprint Code IG;485
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69097-878-02 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:69097-878-03 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:69097-878-07 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:69097-878-12 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206674 07/25/2016
BUPROPION HYDROCHLORIDE (SR) bupropion hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-879
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
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
HYDROCHLORIC ACID
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
FD&C RED NO. 40
Product Characteristics
Color pink Score no score
Shape ROUND Size 12mm
Flavor Imprint Code IG;486
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69097-879-02 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:69097-879-03 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:69097-879-07 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:69097-879-12 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206674 07/25/2016
Labeler — Cipla USA Inc., (078719707)
Registrant — Cipla USA Inc., (078719707)
Establishment
Name Address ID/FEI Operations
InvaGen Pharmaceuticals Inc. 165104469 ANALYSIS (69097-877), ANALYSIS (69097-878), ANALYSIS (69097-879), MANUFACTURE (69097-877), MANUFACTURE (69097-878), MANUFACTURE (69097-879)
Establishment
Name Address ID/FEI Operations
InvaGen Pharmaceuticals Inc. 080334903 ANALYSIS (69097-877), ANALYSIS (69097-878), analysis (69097-879), pack (69097-877), pack (69097-878), pack (69097-879)

Revised: 12/2018 Cipla USA Inc.,

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