WELLBUTRIN XL (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 150 mg Tablets

Rx only

ONCE-DAILY
Wellbutrin XL®
(bupropion hydrochloride
extended-release tablets)

150 mg

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

Federal Law requires dispensing
of WELLBUTRIN XL® with theMedication Guide under this label.

image of 150 mg package label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 300 mg Tablets

Rx only

ONCE-DAILY
Wellbutrin XL®

(bupropion hydrochloride
extended-release tablets)

300 mg

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

Federal Law requires dispensing
of WELLBUTRIN XL® with theMedication Guide under this label.

image of 300 mg package label
(click image for full-size original)
WELLBUTRIN XL bupropion hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5010(NDC:64455-730)
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
ETHYLCELLULOSES
GLYCERYL BEHENATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYVINYL ALCOHOL
POLYETHYLENE GLYCOL
POVIDONE
SILICON DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color white (white to pale yellow) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code WELLBUTRIN;XL;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5010-0 30 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-5010-1 60 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021515 03/02/2004
WELLBUTRIN XL bupropion hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4935(NDC:64455-731)
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
ETHYLCELLULOSES
GLYCERYL BEHENATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYVINYL ALCOHOL
POLYETHYLENE GLYCOL
POVIDONE
SILICON DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color white (white to pale yellow) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code WELLBUTRIN;XL;300
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4935-0 30 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021515 10/08/2003
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 06/2010 Physicians Total Care, Inc.

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