NDC 43353-011

Quetiapine Fumarate

Quetiapine Fumarate

Quetiapine Fumarate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Quetiapine Fumarate.

• Product ID: 43353-011_ba04e9ec-26d0-4ec3-ba89-9443def0c189
• NDC: 43353-011
• Product Type: Human Prescription Drug
• Proprietary Name: Quetiapine Fumarate
• Generic Name: Quetiapine Fumarate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2014-01-17
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077745
• Labeler Name: Aphena Pharma Solutions - Tennessee, LLC
• Substance Name: QUETIAPINE FUMARATE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Atypical Antipsychotic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 43353-011-15

15 TABLET, FILM COATED in 1 BOTTLE (43353-011-15)

• Marketing Start Date: 2015-03-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43353-011-30 [43353001130]

Quetiapine Fumarate TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077745
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-03-26

NDC 43353-011-60 [43353001160]

Quetiapine Fumarate TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077745
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-03-26

NDC 43353-011-15 [43353001115]

Quetiapine Fumarate TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077745
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-03-26

Drug Details

Active Ingredients

Ingredient	Strength
QUETIAPINE FUMARATE	100 mg/1

OpenFDA Data

• SPL SET ID: 14e28312-2fa3-4492-b791-1734b10a8749
• Manufacturer:
  • Aphena Pharma Solutions - Tennessee, LLC
• UNII:
  • 2S3PL1B6UJ
• RxNorm Concept Unique ID - RxCUI:
  • 312743
  • 317174
  • 312745

Pharmacological Class

• Atypical Antipsychotic [EPC]
• 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