NDC 55289-447

SEROQUEL

Quetiapine Fumarate

SEROQUEL is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, In. The primary component is Quetiapine Fuma.

• Product ID: 55289-447_7c1f717a-837e-a2a7-e053-2a91aa0a6e8d
• NDC: 55289-447
• Product Type: Human Prescription Drug
• Proprietary Name: SEROQUEL
• Generic Name: Quetiapine Fumarate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 1997-10-01
• Marketing Category: NDA / NDA
• Application Number: NDA020639
• Labeler Name: PD-Rx Pharmaceuticals, In
• Substance Name: QUETIAPINE FUMA
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Atypical Antips
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55289-447-30

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-447-30)

• Marketing Start Date: 2011-11-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55289-447-30 [55289044730]

SEROQUEL TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020639
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-11-09

Drug Details

Active Ingredients

Ingredient	Strength
QUETIAPINE FUMARATE	200 mg/1

Pharmacological Class

• Atypical Antipsychotic [EPC]

NDC Crossover Matching brand name "SEROQUEL" or generic name "Quetiapine Fumarate"

NDC	Brand Name	Generic Name
21695-119	SEROQUEL	SEROQUEL
21695-117	SEROQUEL	SEROQUEL
21695-118	SEROQUEL	SEROQUEL
21695-120	SEROQUEL	SEROQUEL
55289-447	SEROQUEL	SEROQUEL
55289-187	SEROQUEL	SEROQUEL
55289-872	SEROQUEL	SEROQUEL
0310-0274	SEROQUEL	SEROQUEL
0310-0278	SEROQUEL	SEROQUEL
0310-0271	SEROQUEL	SEROQUEL
0310-0272	SEROQUEL	SEROQUEL
0310-0279	SEROQUEL	SEROQUEL
0310-0275	SEROQUEL	SEROQUEL
63629-3378	SEROQUEL	SEROQUEL
63629-3291	SEROQUEL	SEROQUEL
63629-3380	SEROQUEL	SEROQUEL
63629-3319	SEROQUEL	SEROQUEL
67046-666	SEROQUEL	SEROQUEL
67046-662	SEROQUEL	SEROQUEL
67046-664	SEROQUEL	SEROQUEL
67046-661	SEROQUEL	SEROQUEL
67046-660	SEROQUEL	SEROQUEL
67046-663	SEROQUEL	SEROQUEL
70518-2166	SEROQUEL	SEROQUEL
70518-2424	SEROQUEL	SEROQUEL
0054-0220	Quetiapine Fumarate	Quetiapine Fumarate
0054-0221	Quetiapine Fumarate	Quetiapine Fumarate
0054-0222	Quetiapine Fumarate	Quetiapine Fumarate
0054-0223	Quetiapine Fumarate	Quetiapine Fumarate
0054-0229	Quetiapine Fumarate	Quetiapine Fumarate
0054-0230	Quetiapine Fumarate	Quetiapine Fumarate