NDC 65224-860

Treximet

Sumatriptan Succinate And Naproxen Sodium

Treximet is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pernix Therapeutics. The primary component is Sumatriptan Succinate; Naproxen Sodium.

• Product ID: 65224-860_146f2017-7356-4ccf-8c0c-65b1eb53df8f
• NDC: 65224-860
• Product Type: Human Prescription Drug
• Proprietary Name: Treximet
• Generic Name: Sumatriptan Succinate And Naproxen Sodium
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2015-05-14
• Marketing End Date: 2021-09-30
• Marketing Category: NDA / NDA
• Application Number: NDA021926
• Labeler Name: Pernix Therapeutics
• Substance Name: SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM
• Active Ingredient Strength: 10 mg/1; mg/1
• Pharm Classes: Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: N

Packaging

NDC 65224-860-09

9 TABLET, FILM COATED in 1 BOTTLE (65224-860-09)

• Marketing Start Date: 2015-05-14
• Marketing End Date: 2021-09-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65224-860-09 [65224086009]

Treximet TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021926
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-05-14
• Marketing End Date: 2021-09-30

Drug Details

Active Ingredients

Ingredient	Strength
SUMATRIPTAN SUCCINATE	10 mg/1

OpenFDA Data

• SPL SET ID: 67311f35-35cc-469d-a6eb-cf615af5403a
• Manufacturer:
  • Pernix Therapeutics
• UNII:
  • J8BDZ68989
  • 9TN87S3A3C
• RxNorm Concept Unique ID - RxCUI:
  • 849452
  • 1653765
  • 849450
  • 1653767
• UPC Code:
  • 0365224850092
  • 0365224860091

Pharmacological Class

• Serotonin 1d Receptor Agonists [MoA]
• Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
• Serotonin 1b Receptor Agonists [MoA]
• Cyclooxygenase Inhibitors [MoA]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]

NDC Crossover Matching brand name "Treximet" or generic name "Sumatriptan Succinate And Naproxen Sodium"

NDC	Brand Name	Generic Name
21695-954	TREXIMET	sumatriptan succinate and naproxen sodium
42847-850	Treximet	Sumatriptan Succinate and Naproxen Sodium
65224-850	Treximet	Sumatriptan Succinate and Naproxen Sodium
65224-860	Treximet	Sumatriptan Succinate and Naproxen Sodium
44183-850	Sumatriptan Succinate and Naproxen Sodium	sumatriptan succinate and naproxen sodium