NDC Code(s) : 70436-010-04, 70436-010-06, 70436-010-02, 70436-011-04, 70436-011-06, 70436-011-02
Packager : Slate Run Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bupropion Hydrochloride bupropion hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70436-010
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
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYVINYL ALCOHOL(UNII: 532B59J990)
POLYETHYLENE GLYCOL 1450(UNII: OJ4Z5Z32L4)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SHELLAC(UNII: 46N107B71O)
CYSTEINE HYDROCHLORIDE(UNII: ZT934N0X4W)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color white (white to pale yellow) Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code YH;102
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70436-010-0430 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product12/01/2018
2NDC:70436-010-0690 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product12/01/2018
3NDC:70436-010-02500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product12/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210015 12/01/2018
Bupropion Hydrochloride bupropion hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70436-011
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O)
(BUPROPION - UNII:01ZG3TPX31) 		BUPROPION HYDROCHLORIDE300 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYVINYL ALCOHOL(UNII: 532B59J990)
POLYETHYLENE GLYCOL 1450(UNII: OJ4Z5Z32L4)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
CYSTEINE HYDROCHLORIDE(UNII: ZT934N0X4W)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color white (white to pale yellow) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code YH;101
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70436-011-0430 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product12/01/2018
2NDC:70436-011-0690 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product12/01/2018
3NDC:70436-011-02500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product12/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210015 12/01/2018

LABELER - Slate Run Pharmaceuticals, LLC(039452765)

REGISTRANT - Yichang Humanwell Pharmaceutical Co., Ltd.(527225336)

Establishment
Name Address ID/FEI Business Operations
Yichang Humanwell Oral Solid Dosage Plant 421371958 manufacture(70436-010, 70436-011)

PRINCIPAL DISPLAY PANEL

NDC 70436-010-04

Rx only

ONCE-DAILY
Bupropion Hydrochloride Extended-release Tablets

150 mg
30 Tablets

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.

ZYBAN ® is registered trademark of GlaxoSmithKline.

150mg-30ct

NDC 70436-010-06

Rx only

ONCE-DAILY
Bupropion Hydrochloride Extended-release Tablets

150 mg
90 Tablets

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.

ZYBAN ® is registered trademark of GlaxoSmithKline.

150mg-30ct

NDC 70436-010-02

Rx only

ONCE-DAILY
Bupropion Hydrochloride Extended-release Tablets

150 mg
500 Tablets

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. .

ZYBAN ® is registered trademark of GlaxoSmithKline.

150mg-30ct

PRINCIPAL DISPLAY PANEL

NDC 70436-011-04

Rx only

ONCE-DAILY
Bupropion Hydrochloride Extended-release Tablets

300 mg
30 Tablets

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.

ZYBAN ® is registered trademark of GlaxoSmithKline.

300mg-30ct

NDC 70436-011-06

Rx only

ONCE-DAILY
Bupropion Hydrochloride Extended-release Tablets

300 mg
90 Tablets

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.

ZYBAN ® is registered trademark of GlaxoSmithKline.

300mg-30ct

NDC 70436-011-02

Rx only

ONCE-DAILY
Bupropion Hydrochloride Extended-release Tablets

300 mg
500 Tablets

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.

ZYBAN ® is registered trademark of GlaxoSmithKline.

300mg-30ct