Basic Information
Quetiapine Fumarate
68071-1669
Regulatory Information
68071-1669
ANDA091388
C73584
January 26, 2024
USA
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
HUMAN PRESCRIPTION DRUG LABEL
1
Company Information
010632300
Active Ingredients
POVIDONE K30
Code: U725QWY32X
Class Code: IACT
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
Code: O7TSZ97GEP
Class Code: IACT
HYPROMELLOSE 2910 (6 MPA.S)
Code: 0WZ8WG20P6
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
POLYETHYLENE GLYCOL 400
Code: B697894SGQ
Class Code: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO
Code: 5856J3G2A2
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
Active Moieties
QUETIAPINE
Code: BGL0JSY5SI