NDC 63629-3378

SEROQUEL

Quetiapine Fumarate

SEROQUEL is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Quetiapine Fumarate.

• Product ID: 63629-3378_fc4247a0-dc24-49ea-8798-3f3cc20fea03
• NDC: 63629-3378
• 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: Bryant Ranch Prepack
• Substance Name: QUETIAPINE FUMARATE
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Atypical Antipsychotic [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 63629-3378-5

100 TABLET, FILM COATED in 1 BOTTLE (63629-3378-5)

• Marketing Start Date: 1997-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63629-3378-2 [63629337802]

SEROQUEL TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020639
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1997-10-01
• Inactivation Date: 2019-11-27

NDC 63629-3378-3 [63629337803]

SEROQUEL TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020639
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1997-10-01
• Inactivation Date: 2019-11-27

NDC 63629-3378-5 [63629337805]

SEROQUEL TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020639
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1997-10-01
• Inactivation Date: 2019-11-27

NDC 63629-3378-4 [63629337804]

SEROQUEL TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020639
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1997-10-01
• Inactivation Date: 2019-11-27

NDC 63629-3378-1 [63629337801]

SEROQUEL TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020639
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1997-10-01
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
QUETIAPINE FUMARATE	200 mg/1

OpenFDA Data

• SPL SET ID: ea9c9cbf-7ba9-4df4-be82-c71ad068c9b0
• Manufacturer:
  • Bryant Ranch Prepack
• UNII:
  • 2S3PL1B6UJ
• RxNorm Concept Unique ID - RxCUI:
  • 317174
  • 153640

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