BuPROpion Hydrochloride XL (Page 11 of 11)

PRINCIPAL DISPLAY PANEL

NDC 52817-345-50

Rx Only

Once-Daily

buPROPion Hydrochloride

Extended-Release Tablets, (XL)

150mg

Warning: Do not use in combination with Zyban® or with any other medicine that contains bupropion hydrochloride.

Pharmacists: Dispense the Medication Guide provided separately to each patient.

500 Tablets

TruPharma LLC

LA3455000300 10/2021

Lot:

Exp:

Bup-150mg-500ct
(click image for full-size original)

NDC 52817-345-90

Rx Only

Once-Daily

buPROPion Hydrochloride

Extended-Release Tablets, (XL)

150mg

Warning: Do not use in combination with Zyban® or with any other medicine that contains bupropion hydrochloride.

Pharmacists: Dispense the Medication Guide provided separately to each patient.

90 Tablets

TruPharma LLC

LA3459000300 10/2021

Lot:

Exp:

bup-150 mg-90ct
(click image for full-size original)

NDC 52817-345-30

Rx Only

Once-Daily

buPROPion Hydrochloride

Extended-Release Tablets, (XL)

150mg

Warning: Do not use in combination with Zyban® or with any other medicine that contains bupropion hydrochloride.

Pharmacists: Dispense the Medication Guide provided separately to each patient.

30 Tablets

TruPharma LLC

LA3453000300 10/2021

Lot:

Exp:

bup-tabs-150 mg-30ct
(click image for full-size original)

NDC 52817-346-50

Rx Only

Once-Daily

buPROPion Hydrochloride

Extended-Release Tablets, (XL)

300mg

Warning: Do not use in combination with Zyban® or with any other medicine that contains bupropion hydrochloride.

Pharmacists: Dispense the Medication Guide provided separately to each patient.

500 Tablets

TruPharma LLC

LA3465000300 10/2021

Lot:

Exp:

Bupropion HCL ER Tab 300 mg 500 count
(click image for full-size original)

NDC 52817-346-90

Rx Only

Once-Daily

buPROPion Hydrochloride

Extended-Release Tablets, (XL)

300mg

Warning: Do not use in combination with Zyban® or with any other medicine that contains bupropion hydrochloride.

Pharmacists: Dispense the Medication Guide provided separately to each patient.

500 Tablets

TruPharma LLC

LA3469000300 10/2021

Lot:

Exp:

Bupropion HCL ER Tab 300 mg 90 count
(click image for full-size original)

NDC 52817-346-30

Rx Only

Once-Daily

buPROPion Hydrochloride

Extended-Release Tablets, (XL)

300mg

Warning: Do not use in combination with Zyban® or with any other medicine that contains bupropion hydrochloride.

Pharmacists: Dispense the Medication Guide provided separately to each patient.

30 Tablets

TruPharma LLC

LA3463000300 10/2021

Lot:

Exp:

Bupro-ER-Tabs-XL-300 mg 30 ct
(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:52817-345
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
ALCOHOL
ETHYLCELLULOSE, UNSPECIFIED
HYDROCHLORIC ACID
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
STEARIC ACID
TALC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
WATER
Product Characteristics
Color white (white to off white) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code T010
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52817-345-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:52817-345-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:52817-345-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211200 01/26/2022
BUPROPION HYDROCHLORIDE XL bupropion hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52817-346
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
ALCOHOL
ETHYLCELLULOSE, UNSPECIFIED
HYDROCHLORIC ACID
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
STEARIC ACID
TALC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
WATER
Product Characteristics
Color white (white to off white) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code T011
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52817-346-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:52817-346-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:52817-346-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211200 01/27/2022
Labeler — TruPharma LLC (078533947)
Registrant — Tulex Pharmaceuticals Inc (080119240)
Establishment
Name Address ID/FEI Operations
Tulex Pharmaceuticals, Inc. 080119240 analysis (52817-346), manufacture (52817-346), pack (52817-346), analysis (52817-345), manufacture (52817-345), pack (52817-345)

Revised: 01/2022 TruPharma LLC

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