NDC Code(s) : 50228-174-30, 50228-174-60, 50228-174-01, 50228-174-05, 50228-174-10, 50228-175-30, 50228-175-60, 50228-175-01, 50228-175-05, 50228-175-10, 50228-176-30, 50228-176-60, 50228-176-01, 50228-176-10
Packager : ScieGen Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50228-174
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
COPOVIDONE K25-31(UNII: D9C330MD8B)
CYSTEINE HYDROCHLORIDE(UNII: ZT934N0X4W)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
ALCOHOL(UNII: 3K9958V90M)
ACACIA(UNII: 5C5403N26O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color blue Score no score
Shape ROUND (biconvex) Size 9 mm
Flavor Imprint Code SG;174
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50228-174-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/04/2018
2NDC:50228-174-6060 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/04/2018
3NDC:50228-174-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/04/2018
4NDC:50228-174-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/04/2018
5NDC:50228-174-101000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/04/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205794 04/20/2018
Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50228-175
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O)
(BUPROPION - UNII:01ZG3TPX31) 		BUPROPION HYDROCHLORIDE150 mg
Inactive Ingredients
Ingredient Name Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
ALCOHOL(UNII: 3K9958V90M)
ACACIA(UNII: 5C5403N26O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
COPOVIDONE K25-31(UNII: D9C330MD8B)
CYSTEINE HYDROCHLORIDE(UNII: ZT934N0X4W)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color purple Score no score
Shape ROUND (biconvex) Size 11 mm
Flavor Imprint Code SG;175
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50228-175-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/04/2018
2NDC:50228-175-6060 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/04/2018
3NDC:50228-175-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/04/2018
4NDC:50228-175-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/04/2018
5NDC:50228-175-101000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/04/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205794 04/20/2018
Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50228-176
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O)
(BUPROPION - UNII:01ZG3TPX31) 		BUPROPION HYDROCHLORIDE200 mg
Inactive Ingredients
Ingredient Name Strength
COPOVIDONE K25-31(UNII: D9C330MD8B)
CYSTEINE HYDROCHLORIDE(UNII: ZT934N0X4W)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C RED NO. 40(UNII: WZB9127XOA)
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
ALCOHOL(UNII: 3K9958V90M)
ACACIA(UNII: 5C5403N26O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color pink Score no score
Shape ROUND (biconvex) Size 12 mm
Flavor Imprint Code SG;176
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50228-176-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/04/2018
2NDC:50228-176-6060 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/04/2018
3NDC:50228-176-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/04/2018
4NDC:50228-176-101000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/04/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205794 04/20/2018

LABELER - ScieGen Pharmaceuticals, Inc.(079391286)

Establishment
Name Address ID/FEI Business Operations
ScieGen Pharmaceuticals, Inc. 079391286 analysis(50228-174, 50228-175, 50228-176), manufacture(50228-174, 50228-175, 50228-176)

PRINCIPAL DISPLAY PANEL

NDC 50228-174-30

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.

30 Tablets Rx only

ScieGen Pharmaceuticals, Inc.

bupropion HCL 100 mg 30 Extended-Release Tablet, USP Label

NDC 50228-174-60

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 any other medicines that contain
bupropion hydrochloride.

60 Tablets Rx Only

ScieGen Pharmaceuticals Inc.

bupropion HCL 100 mg 30 Extended-Release Tablet, USP Label

NDC 50228-174-01

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.

100 Tablets Rx Only

ScieGen Pharmaceuticals Inc.

bupropion HCL 100 mg 30 Extended-Release Tablet, USP Label

NDC 50228-174-05

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.

500 Tablets Rx Only

ScieGen Pharmaceuticals Inc.

bupropion HCL 100 mg 30 Extended-Release Tablet, USP Label

NDC 50228-174-10

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.

1,000 Tablets Rx only

ScieGen Pharmaceuticals, Inc.

bupropion HCL 100 mg 30 Extended-Release Tablet, USP Label

NDC 50228-175-30

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.

30 Tablets Rx only

ScieGen Pharmaceuticals, Inc.

bupropion HCL 100 mg 30 Extended-Release Tablet, USP Label

NDC 50228-175-60

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.

60 Tablets Rx Only

ScieGen Pharmaceuticals Inc.

bupropion HCL 100 mg 30 Extended-Release Tablet, USP Label

NDC 50228-175-01

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.

100 Tablets Rx Only

ScieGen Pharmaceuticals Inc.

bupropion HCL 100 mg 30 Extended-Release Tablet, USP Label

NDC 50228-175-05

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.

500 Tablets Rx Only

ScieGen Pharmaceuticals Inc.

bupropion HCL 100 mg 30 Extended-Release Tablet, USP Label

NDC 50228-175-10

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.

1,000 Tablets Rx 0nly

ScieGen Pharmaceuticals, Inc.

bupropion HCL 100 mg 30 Extended-Release Tablet, USP Label

NDC 50228-176-30

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.

30 Tablets Rx only

ScieGen Pharmaceuticals, Inc.

bupropion HCL 100 mg 30 Extended-Release Tablet, USP Label

NDC 50228-176-60

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.

60 Tablets Rx Only

ScieGen Pharmaceuticals Inc.

bupropion HCL 100 mg 30 Extended-Release Tablet, USP Label

NDC 50228-176-01

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.

100 Tablets Rx Only

ScieGen Pharmaceuticals Inc.

bupropion HCL 100 mg 30 Extended-Release Tablet, USP Label

NDC 50228-176-10

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.

1,000 Tablets Rx only

ScieGen Pharmaceuticals, Inc.

bupropion HCL 100 mg 30 Extended-Release Tablet, USP Label