NDC 0310-0278

SEROQUEL

Quetiapine Fumarate

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

• Product ID: 0310-0278_0ea67c30-9548-480f-99de-7678dc88a648
• NDC: 0310-0278
• Product Type: Human Prescription Drug
• Proprietary Name: SEROQUEL
• Generic Name: Quetiapine Fumarate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2006-02-13
• Marketing Category: NDA / NDA
• Application Number: NDA020639
• Labeler Name: AstraZeneca Pharmaceuticals LP
• Substance Name: QUETIAPINE FUMARATE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Atypical Antipsychotic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0310-0278-10

100 TABLET, FILM COATED in 1 BOTTLE (0310-0278-10)

• Marketing Start Date: 2006-02-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-0278-34 [00310027834]

SEROQUEL TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020639
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2006-02-13
• Marketing End Date: 2015-09-07

NDC 0310-0278-10 [00310027810]

SEROQUEL TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020639
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2006-02-13

NDC 0310-0278-39 [00310027839]

SEROQUEL TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020639
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2006-02-13
• Marketing End Date: 2015-11-30

Drug Details

Active Ingredients

Ingredient	Strength
QUETIAPINE FUMARATE	50 mg/1

OpenFDA Data

• SPL SET ID: 0584dda8-bc3c-48fe-1a90-79608f78e8a0
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • 2S3PL1B6UJ
• RxNorm Concept Unique ID - RxCUI:
  • 317174
  • 616489
  • 284509
  • 616485
  • 616483
  • 616487
  • 153640
  • 312743
  • 153638
  • 153639
  • 312745
  • 312744

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