Quetiapine

Basic Information

Product Name

Quetiapine

FDA Product Code

0093-8164

Regulatory Information

NDC Product Code

0093-8164

Application Number

ANDA077745

Marketing Category

C73584

Effective Date

August 10, 2022

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS.QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

DIBASIC CALCIUM PHOSPHATE DIHYDRATE

Code: O7TSZ97GEP

Class Code: IACT

HYPROMELLOSE 2910 (15 MPA.S)

Code: 36SFW2JZ0W

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

POVIDONE K27

Code: H7AGY1OJO8

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

QUETIAPINE FUMARATE

Quantity: 300 mg in 1 1

Code: 2S3PL1B6UJ

Class Code: ACTIM

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

POVIDONE K25

Code: K0KQV10C35

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

Active Moieties

Code: BGL0JSY5SI

Quetiapine

Basic Information

Regulatory Information

Company Information

Active Ingredients

DIBASIC CALCIUM PHOSPHATE DIHYDRATE

HYPROMELLOSE 2910 (15 MPA.S)

LACTOSE MONOHYDRATE

POVIDONE K27

MAGNESIUM STEARATE

SODIUM STARCH GLYCOLATE TYPE A POTATO

TITANIUM DIOXIDE

SILICON DIOXIDE

MICROCRYSTALLINE CELLULOSE

POVIDONE K25

TRIACETIN

FERRIC OXIDE YELLOW

Active Moieties

QUETIAPINE