NDC 65862-876

Quetiapine Fumarate

Quetiapine

Quetiapine Fumarate is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Quetiapine Fumarate.

• Product ID: 65862-876_16429227-b3bd-49bc-8a6a-63d0f53c9017
• NDC: 65862-876
• Product Type: Human Prescription Drug
• Proprietary Name: Quetiapine Fumarate
• Generic Name: Quetiapine
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2017-11-29
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207655
• Labeler Name: Aurobindo Pharma Limited
• Substance Name: QUETIAPINE FUMARATE
• Active Ingredient Strength: 300 mg/1
• Pharm Classes: Atypical Antipsychotic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 65862-876-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-876-01)

• Marketing Start Date: 2017-11-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65862-876-01 [65862087601]

Quetiapine Fumarate TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA207655
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-11-29

NDC 65862-876-60 [65862087660]

Quetiapine Fumarate TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA207655
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-11-29

NDC 65862-876-05 [65862087605]

Quetiapine Fumarate TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA207655
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-11-29

Drug Details

Active Ingredients

Ingredient	Strength
QUETIAPINE FUMARATE	300 mg/1

OpenFDA Data

• SPL SET ID: 6562eb60-0d70-4909-bd07-88d5c9241516
• Manufacturer:
  • Aurobindo Pharma Limited
• UNII:
  • 2S3PL1B6UJ
• RxNorm Concept Unique ID - RxCUI:
  • 721796
  • 853201
  • 721794
  • 895670
  • 721791

Pharmacological Class

• Atypical Antipsychotic [EPC]

Medicade Reported Pricing

65862087660 QUETIAPINE ER 300 MG TABLET

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
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
67877-242	Quetiapine Fumarate	Quetiapine Fumarate
67877-249	Quetiapine Fumarate	Quetiapine Fumarate
67877-250	Quetiapine Fumarate	Quetiapine Fumarate
67877-246	Quetiapine Fumarate	Quetiapine Fumarate
67877-248	Quetiapine Fumarate	Quetiapine Fumarate
67877-245	Quetiapine Fumarate	Quetiapine Fumarate
67877-247	Quetiapine Fumarate	Quetiapine Fumarate
68001-183	Quetiapine fumarate	Quetiapine fumarate
68001-182	Quetiapine fumarate	Quetiapine fumarate
68001-184	Quetiapine fumarate	Quetiapine fumarate
68001-180	Quetiapine fumarate	Quetiapine fumarate
68001-185	Quetiapine fumarate	Quetiapine fumarate
68001-181	Quetiapine fumarate	Quetiapine fumarate
68071-1892	Quetiapine Fumarate	Quetiapine Fumarate
68180-450	Quetiapine fumarate	Quetiapine fumarate
68180-447	Quetiapine fumarate	Quetiapine fumarate
68180-448	Quetiapine fumarate	Quetiapine fumarate
68151-5225	Quetiapine Fumarate	Quetiapine Fumarate
68180-614	Quetiapine fumarate	Quetiapine fumarate
68180-613	Quetiapine fumarate	Quetiapine fumarate
68180-615	Quetiapine fumarate	Quetiapine fumarate
68180-616	Quetiapine fumarate	Quetiapine fumarate
68180-445	Quetiapine fumarate	Quetiapine fumarate
68180-446	Quetiapine fumarate	Quetiapine fumarate
68180-612	Quetiapine fumarate	Quetiapine fumarate
68180-449	Quetiapine fumarate	Quetiapine fumarate
68788-7195	Quetiapine fumarate	Quetiapine fumarate
68788-9487	Quetiapine fumarate	Quetiapine fumarate
68788-9490	Quetiapine Fumarate	Quetiapine Fumarate
69189-0495	Quetiapine Fumarate	Quetiapine Fumarate
69189-0580	Quetiapine Fumarate	Quetiapine Fumarate
70518-0753	quetiapine fumarate	quetiapine fumarate
70518-0767	Quetiapine fumarate	Quetiapine fumarate
70518-0556	Quetiapine fumarate	Quetiapine fumarate
70518-0638	Quetiapine Fumarate	Quetiapine Fumarate
70518-0594	Quetiapine fumarate	Quetiapine fumarate
70518-0645	Quetiapine Fumarate	Quetiapine Fumarate
70518-0974	Quetiapine Fumarate	Quetiapine Fumarate
70518-1018	Quetiapine Fumarate	Quetiapine Fumarate
70518-1029	quetiapine fumarate	quetiapine fumarate
70518-0975	Quetiapine Fumarate	Quetiapine Fumarate
70518-0989	Quetiapine Fumarate	Quetiapine Fumarate
70518-0723	Quetiapine Fumarate	Quetiapine Fumarate
70518-0988	Quetiapine fumarate	Quetiapine fumarate