NDC 21695-954

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 Rebel Distributors Corp. The primary component is Sumatriptan Succinate; Naproxen Sodium.

• Product ID: 21695-954_e08d5f22-f9c3-4627-8e5a-72c95183cf6a
• NDC: 21695-954
• 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: 2008-04-25
• Marketing Category: NDA / NDA
• Application Number: NDA021926
• Labeler Name: Rebel Distributors Corp
• Substance Name: SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM
• Active Ingredient Strength: 85 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],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 21695-954-09

9 TABLET, FILM COATED in 1 CONTAINER (21695-954-09)

• Marketing Start Date: 2008-04-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 21695-954-09 [21695095409]

TREXIMET TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021926
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-04-25
• Inactivation Date: 2019-09-24

Drug Details

Active Ingredients

Ingredient	Strength
SUMATRIPTAN SUCCINATE	85 mg/1

OpenFDA Data

• SPL SET ID: e08d5f22-f9c3-4627-8e5a-72c95183cf6a
• Manufacturer:
  • Rebel Distributors Corp
• UNII:
  • J8BDZ68989
  • 9TN87S3A3C
• RxNorm Concept Unique ID - RxCUI:
  • 849452
  • 849450

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