Wellbutrin, Page 6

Wellbutrin (bupropion hydrochloride) is an antidepressant of the aminoketone class and is indicated for the treatment of major depressive disorder. While not approved for smoking cessation treatment, bupropion under the name Zyban is approved for this use. Effectiveness of Wellbutrin in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials.

Principal Display Panel

NDC 0173-0177-55

WELLBUTRIN®

(bupropion HCl)

Tablets

Three Times Daily

(After Initial Titration)

75 mg

WARNING: Do not use with other medicines that contain bupropion HCl.

Federal Law requires dispensing of WELLBUTRIN® with the Medication Guide under this label.

Rx only

100 Tablets

Each film-coated tablet contains 75 mg bupropion HCl.

See prescribing information for dosage information.

Store at 15o to 25oC (59o to 77oF). Protect from moisture.

Manufactured by DSM Pharmaceuticals, Inc.

Greenville, NC 27834

for GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Germany

10000000071898

Rev. 8/09

75 mg, 100-tablet bottle label

Principal Display Panel

NDC 0173-0178-55

WELLBUTRIN®

(bupropion HCl)

Tablets

Three Times Daily

(After Initial Titration)

100 mg

WARNING: Do not use with other medicines that contain bupropion HCl.

Federal Law requires dispensing of WELLBUTRIN® with the Medication Guide under this label.

Rx only

100 Tablets

Each film-coated tablet contains 100 mg bupropion HCl.

See prescribing information for dosage information.

Store at 15o to 25oC (59o to 77oF). Protect from moisture.

Manufactured by DSM Pharmaceuticals, Inc.

Greenville, NC 27834

for GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Germany

10000000071899

Rev. 8/09

75 mg, 100-tablet bottle label

WELLBUTRIN
bupropion hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0177
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE (BUPROPION) BUPROPION HYDROCHLORIDE 75 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
TALC
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
Product Characteristics
Color YELLOW (yellow-gold) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code WELLBUTRIN;75
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0173-0177-55 100 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018644 02/04/1986
WELLBUTRIN
bupropion hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0178
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
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
TALC
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
FD&C RED NO. 40
Product Characteristics
Color RED Score no score
Shape ROUND Size 12mm
Flavor Imprint Code WELLBUTRIN;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0173-0178-55 100 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018644 06/21/1989
Labeler — GlaxoSmithKline LLC (167380711)

Revised: 05/2011 GlaxoSmithKline LLC

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