NDC 54766-907

BRISDELLE

Paroxetine

BRISDELLE is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Sebela Pharmaceuticals Inc.. The primary component is Paroxetine Mesylate.

• Product ID: 54766-907_673aadab-c67a-6c69-e053-2991aa0a136c
• NDC: 54766-907
• Product Type: Human Prescription Drug
• Proprietary Name: BRISDELLE
• Generic Name: Paroxetine
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2017-05-23
• Marketing Category: NDA / NDA
• Application Number: NDA204516
• Labeler Name: Sebela Pharmaceuticals Inc.
• Substance Name: PAROXETINE MESYLATE
• Active Ingredient Strength: 8 mg/1
• Pharm Classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 54766-907-53

30 CAPSULE in 1 BLISTER PACK (54766-907-53)

• Marketing Start Date: 2017-05-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54766-907-53 [54766090753]

BRISDELLE CAPSULE

• Marketing Category: NDA
• Application Number: NDA204516
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-05-23

Drug Details

Active Ingredients

Ingredient	Strength
PAROXETINE MESYLATE	7.5 mg/1

OpenFDA Data

• SPL SET ID: 50361fc8-8fba-1c45-e054-00144ff88e88
• Manufacturer:
  • Sebela Pharmaceuticals Inc.
• UNII:
  • M711N184JE
• RxNorm Concept Unique ID - RxCUI:
  • 1430122
  • 1430128

Pharmacological Class

• Serotonin Reuptake Inhibitor [EPC]
• Serotonin Uptake Inhibitors [MoA]
• Serotonin Reuptake Inhibitor [EPC]
• Serotonin Uptake Inhibitors [MoA]

Medicade Reported Pricing

54766090753 BRISDELLE 7.5 MG CAPSULE

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "BRISDELLE" or generic name "Paroxetine"

NDC	Brand Name	Generic Name
54766-907	BRISDELLE	BRISDELLE
0574-0279	Paroxetine	paroxetine
0615-5576	Paroxetine	Paroxetine
0615-5577	Paroxetine	Paroxetine
0615-5578	Paroxetine	Paroxetine
0615-5579	Paroxetine	Paroxetine
0615-8173	Paroxetine	Paroxetine
0615-8174	Paroxetine	Paroxetine
0615-8359	Paroxetine	Paroxetine
13107-154	Paroxetine	Paroxetine
13107-155	Paroxetine	Paroxetine
13107-156	Paroxetine	Paroxetine
13107-157	Paroxetine	Paroxetine
33261-090	Paroxetine	Paroxetine
33261-091	Paroxetine	Paroxetine
35356-892	Paroxetine	Paroxetine
43353-713	Paroxetine	Paroxetine
43547-409	PAROXETINE	paroxetine
50090-0848	Paroxetine	Paroxetine
50090-0921	Paroxetine	Paroxetine
50090-2143	Paroxetine	Paroxetine
50268-640	Paroxetine	Paroxetine