Bupropion Hydrochloride (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ONCE-DAILY

NDC 70377-034-12

buPROPion Hydrochloride Extended-Release Tablets, USP (XL)

150 mg

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.

Rx Only

90 Tablets

image
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ONCE-DAILY

NDC 70377-035-12

buPROPion Hydrochloride Extended-Release Tablets, USP (XL)

300 mg

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.

Rx Only

90 Tablets

image
(click image for full-size original)
BUPROPION HYDROCHLORIDE bupropion hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-034
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 (100 MPA.S)
GLYCERYL DIBEHENATE
HYDROCHLORIC ACID
MAGNESIUM STEARATE
METHYLENE CHLORIDE
POLYETHYLENE GLYCOL 1450
POVIDONE K90
SILICON DIOXIDE
TRIETHYL CITRATE
HYPROMELLOSE, UNSPECIFIED
TRICETIN
TALC
SHELLAC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
AMMONIA
METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
Product Characteristics
Color WHITE (white pale to yellow) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 188
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70377-034-11 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70377-034-12 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:70377-034-13 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211020 01/28/2019
BUPROPION HYDROCHLORIDE bupropion hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-035
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 (100 MPA.S)
GLYCERYL DIBEHENATE
HYDROCHLORIC ACID
MAGNESIUM STEARATE
METHYLENE CHLORIDE
POLYETHYLENE GLYCOL 1450
POVIDONE K90
SILICON DIOXIDE
TRIETHYL CITRATE
HYPROMELLOSE, UNSPECIFIED
TRICETIN
TALC
SHELLAC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
AMMONIA
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
Product Characteristics
Color WHITE (white pale yellow) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 189
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70377-035-11 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70377-035-12 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:70377-035-13 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211020 01/28/2019
Labeler — Biocon Pharma Inc., (080000063)
Establishment
Name Address ID/FEI Operations
Graviti Pharmaceuticals Private Limited 650884781 MANUFACTURE (70377-034), MANUFACTURE (70377-035), ANALYSIS (70377-034), ANALYSIS (70377-035)

Revised: 12/2020 Biocon Pharma Inc.,

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