Bupropion Hydrochloride: Package Insert and Label Information (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68180-319-06

Bupropion Hydrochloride Extended-release Tablets USP (XL)

150 mg

Rx only

Bottle of 30 Tablets

150 mg
(click image for full-size original)

NDC 68180-320-06

Bupropion Hydrochloride Extended-release Tablets USP (XL)

300 mg

Rx only

Bottle of 30 Tablets

300 mg
(click image for full-size original)
BUPROPION HYDROCHLORIDE bupropion hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-319
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
AMMONIA
CYSTEINE HYDROCHLORIDE
DIBUTYL SEBACATE
ETHYLCELLULOSES
FERROSOFERRIC OXIDE
GLYCERYL BEHENATE/EICOSADIOATE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE
PROPYLENE GLYCOL
SHELLAC
SILICA DIMETHYL SILYLATE
SILICON DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color WHITE (off-white to pale yellow) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code L015
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-319-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68180-319-09 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:68180-319-02 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090693 06/14/2017
BUPROPION HYDROCHLORIDE bupropion hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-320
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
AMMONIA
CYSTEINE HYDROCHLORIDE
DIBUTYL SEBACATE
ETHYLCELLULOSES
FERROSOFERRIC OXIDE
GLYCERYL BEHENATE/EICOSADIOATE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE
PROPYLENE GLYCOL
SHELLAC
SILICA DIMETHYL SILYLATE
SILICON DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color WHITE (off-white to pale yellow) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code L016
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-320-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68180-320-09 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:68180-320-02 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090693 06/14/2017
Labeler — Lupin Pharmaceuticals, Inc. (089153071)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 677600414 MANUFACTURE (68180-319), MANUFACTURE (68180-320), PACK (68180-319), PACK (68180-320)

Revised: 04/2023 Lupin Pharmaceuticals, Inc.

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