NDC 54766-201

PEXEVA

Paroxetine Mesylate

PEXEVA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sebela Pharmaceuticals Inc.. The primary component is Paroxetine Mesylate.

• Product ID: 54766-201_7d24951f-636d-74ed-e053-2a91aa0aa29a
• NDC: 54766-201
• Product Type: Human Prescription Drug
• Proprietary Name: PEXEVA
• Generic Name: Paroxetine Mesylate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-06-02
• Marketing Category: NDA / NDA
• Application Number: NDA021299
• Labeler Name: Sebela Pharmaceuticals Inc.
• Substance Name: PAROXETINE MESYLATE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 54766-201-01

30 TABLET, FILM COATED in 1 BOTTLE (54766-201-01)

• Marketing Start Date: 2017-06-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54766-201-01 [54766020101]

PEXEVA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021299
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-06-02

Drug Details

Active Ingredients

Ingredient	Strength
PAROXETINE MESYLATE	10 mg/1

OpenFDA Data

• SPL SET ID: 50fe88bd-f0dd-5fad-e054-00144ff8d46c
• Manufacturer:
  • Sebela Pharmaceuticals Inc.
• UNII:
  • M711N184JE
• RxNorm Concept Unique ID - RxCUI:
  • 1738523
  • 1738519
  • 1738527
  • 1738515
  • 541662
  • 541660
  • 541666
  • 541664
• UPC Code:
  • 0354766204012
  • 0354766202018
  • 0354766201011
  • 0354766203015

Pharmacological Class

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

NDC Crossover Matching brand name "PEXEVA" or generic name "Paroxetine Mesylate"

NDC	Brand Name	Generic Name
54766-201	PEXEVA	paroxetine mesylate
54766-202	PEXEVA	paroxetine mesylate
54766-203	PEXEVA	paroxetine mesylate
54766-204	PEXEVA	paroxetine mesylate