Bupropion Hydrochloride XL (Page 9 of 9)

PRINCIPAL DISPLAY PANEL – 150 mg Tablet Bottle Label

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
(click image for full-size original)

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-90ct
(click image for full-size original)

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-500ct
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 300 mg Tablet Bottle Label

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
(click image for full-size original)

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-90ct
(click image for full-size original)

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-500ct
(click image for full-size original)
BUPROPION HYDROCHLORIDE XL 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 (BUPROPION) BUPROPION HYDROCHLORIDE 150 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE, UNSPECIFIED
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYVINYL ALCOHOL
POLYETHYLENE GLYCOL 1450
POLYETHYLENE GLYCOL 3350
POVIDONE
SILICON DIOXIDE
TRIETHYL CITRATE
TITANIUM DIOXIDE
TALC
LECITHIN, SOYBEAN
FERROSOFERRIC OXIDE
SHELLAC
CYSTEINE HYDROCHLORIDE
MAGNESIUM STEARATE
Product Characteristics
Color white (white to pale yellow) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code YH;102
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70436-010-04 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:70436-010-06 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
3 NDC:70436-010-02 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210015 12/01/2018
BUPROPION HYDROCHLORIDE XL 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 (BUPROPION) BUPROPION HYDROCHLORIDE 300 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE, UNSPECIFIED
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYVINYL ALCOHOL
POLYETHYLENE GLYCOL 1450
POLYETHYLENE GLYCOL 3350
POVIDONE
SILICON DIOXIDE
TRIETHYL CITRATE
TITANIUM DIOXIDE
TALC
LECITHIN, SOYBEAN
SHELLAC
FERROSOFERRIC OXIDE
CYSTEINE HYDROCHLORIDE
MAGNESIUM STEARATE
Product Characteristics
Color white (white to pale yellow) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code YH;101
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70436-011-04 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:70436-011-06 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
3 NDC:70436-011-02 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
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 Operations
Yichang Humanwell Oral Solid Dosage Plant 421371958 manufacture (70436-010), manufacture (70436-011)

Revised: 06/2021 Slate Run Pharmaceuticals, LLC

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