NDC Code(s) : 63304-723-30, 63304-723-90, 63304-723-05
Packager : Sun Pharmaceutical Industries, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bupropion hydrochlorideBupropion hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-723
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O)
(BUPROPION - UNII:01ZG3TPX31) 		BUPROPION HYDROCHLORIDE150 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
STEARIC ACID(UNII: 4ELV7Z65AP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
Product Characteristics
Color WHITE (white to pale yellow) Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code L2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63304-723-3030 in 1 BOTTLE Type 0: Not a Combination Product12/09/2020
2NDC:63304-723-9090 in 1 BOTTLE Type 0: Not a Combination Product12/09/2020
3NDC:63304-723-05500 in 1 BOTTLE Type 0: Not a Combination Product12/09/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200216 12/09/2020

LABELER - Sun Pharmaceutical Industries, Inc.(146974886)

REGISTRANT - Sun Pharmaceutical Industries, Inc.(146974886)

Establishment
Name Address ID/FEI Business Operations
Sun Pharmaceutical Industries Limited 650456002 MANUFACTURE(63304-723)

PRINCIPAL DISPLAY PANEL

ONCE-DAILY

NDC 63304-723-30

buPROPion HCl 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 with Medication Guide to each patient

Rx only

  •   30 tablets SUN PHARMA
spl-bupropion-label1

PRINCIPAL DISPLAY PANEL

ONCE-DAILY

NDC 63304-723-90

buPROPion HCl 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 with Medication Guide to each patient

Rx only

  •   90 tablets SUN PHARMA
spl-bupropion-label2

PRINCIPAL DISPLAY PANEL

ONCE-DAILY

NDC 63304-723-05

buPROPion HCl 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 with Medication Guide to each patient

Rx only

  •   500 tablets SUN PHARMA
spl-bupropion-label3