NDC 57297-450

Quetiapine fumarate

Quetiapine Fumarate

Quetiapine fumarate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lupin Limited. The primary component is Quetiapine Fumarate.

• Product ID: 57297-450_28b08037-0fdb-4dd9-a3e4-e9bba5ca8948
• NDC: 57297-450
• Product Type: Human Prescription Drug
• Proprietary Name: Quetiapine fumarate
• Generic Name: Quetiapine Fumarate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2012-03-27
• Marketing Category: ANDA / ANDA
• Application Number: ANDA201109
• Labeler Name: LUPIN LIMITED
• Substance Name: QUETIAPINE FUMARATE
• Active Ingredient Strength: 400 mg/1
• Pharm Classes: Atypical Antipsychotic [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 57297-450-02

500 TABLET in 1 BOTTLE (57297-450-02)

• Marketing Start Date: 2012-03-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57297-450-02 [57297045002]

Quetiapine fumarate TABLET

• Marketing Category: ANDA
• Application Number: ANDA201109
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-03-27
• Inactivation Date: 2020-01-31

NDC 57297-450-13 [57297045013]

Quetiapine fumarate TABLET

• Marketing Category: ANDA
• Application Number: ANDA201109
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-03-27
• Inactivation Date: 2020-01-31

NDC 57297-450-01 [57297045001]

Quetiapine fumarate TABLET

• Marketing Category: ANDA
• Application Number: ANDA201109
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-03-27
• Inactivation Date: 2020-01-31

NDC 57297-450-03 [57297045003]

Quetiapine fumarate TABLET

• Marketing Category: ANDA
• Application Number: ANDA201109
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-03-27
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
QUETIAPINE FUMARATE	400 mg/1

OpenFDA Data

• SPL SET ID: b519b924-2348-46ac-b9a2-c9c198257ea4
• Manufacturer:
  • LUPIN LIMITED
• UNII:
  • 2S3PL1B6UJ
• RxNorm Concept Unique ID - RxCUI:
  • 616487
  • 616483
  • 312743
  • 317174
  • 312745
  • 312744

Pharmacological Class

• Atypical Antipsychotic [EPC]

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

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