NDC Code(s) : 69844-010-01, 69844-010-02, 69844-010-03, 69844-011-01, 69844-011-02, 69844-011-03
Packager : Graviti Pharmaceuticals Private Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-010
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O)
(BUPROPION - UNII:01ZG3TPX31) 		BUPROPION HYDROCHLORIDE300 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE (100 MPA.S)(UNII: 47MLB0F1MV)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
HYDROCHLORIC ACID(UNII: QTT17582CB)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHYLENE CHLORIDE(UNII: 588X2YUY0A)
POLYETHYLENE GLYCOL 1450(UNII: OJ4Z5Z32L4)
POVIDONE K90(UNII: RDH86HJV5Z)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
TRIACETIN(UNII: XHX3C3X673)
TALC(UNII: 7SEV7J4R1U)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
AMMONIA(UNII: 5138Q19F1X)
METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
Product Characteristics
Color WHITE (white to pale yellow) Score no score
Shape ROUND (biconvex coated) Size 9 mm
Flavor Imprint Code 189
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69844-010-0130 in 1 BOTTLE Type 0: Not a Combination Product28/01/2019
2NDC:69844-010-0290 in 1 BOTTLE Type 0: Not a Combination Product28/01/2019
3NDC:69844-010-031000 in 1 BOTTLE Type 0: Not a Combination Product28/01/2019
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:69844-011
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 (100 MPA.S)(UNII: 47MLB0F1MV)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
HYDROCHLORIC ACID(UNII: QTT17582CB)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHYLENE CHLORIDE(UNII: 588X2YUY0A)
POLYETHYLENE GLYCOL 1450(UNII: OJ4Z5Z32L4)
POVIDONE K90(UNII: RDH86HJV5Z)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
TRIACETIN(UNII: XHX3C3X673)
TALC(UNII: 7SEV7J4R1U)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
AMMONIA(UNII: 5138Q19F1X)
METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
Product Characteristics
Color WHITE (white to pale yellow) Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code 188
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69844-011-0130 in 1 BOTTLE Type 0: Not a Combination Product28/01/2019
2NDC:69844-011-0290 in 1 BOTTLE Type 0: Not a Combination Product28/01/2019
3NDC:69844-011-031000 in 1 BOTTLE Type 0: Not a Combination Product28/01/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211020 01/28/2019

LABELER - Graviti Pharmaceuticals Private Limited(650884781)

Establishment
Name Address ID/FEI Business Operations
Graviti Pharmaceuticals Private Limited 650884781 MANUFACTURE(69844-010, 69844-011), ANALYSIS(69844-010, 69844-011)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 300 mg Tablet Bottle Label

NDC 69844-010-01

30 Tablets

Rx only

Bupropion Hydrochloride Delayed-Release Tablets, USP (XL)

300 mg

Manufactured for Graviti Pharmaceuticals Inc.

Made in India.

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NDC 69844-011-01

30 Tablets

Rx only

Bupropion Hydrochloride Delayed-Release Tablets, USP (XL)

150 mg

Manufactured for Graviti Pharmaceuticals Inc.

Made in India.

image