NDC 55289-187

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: 55289-187_7bd52a08-4ed8-7b60-e053-2a91aa0aae61
• NDC: 55289-187
• 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: 100 mg/1
• Pharm Classes: Atypical Antips
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55289-187-30

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-187-30)

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

NDC SPL Data Element Entries

NDC 55289-187-30 [55289018730]

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	100 mg/1

OpenFDA Data

• SPL SET ID: 3ea59594-8a2b-4b64-9aa8-1d53d9027bb0
• Manufacturer:
  • PD-Rx Pharmaceuticals, Inc.
• UNII:
  • 2S3PL1B6UJ
• RxNorm Concept Unique ID - RxCUI:
  • 312743
  • 153639
• UPC Code:
  • 0355289187301

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