NDC 16714-891

Sumatriptan and Naproxen Sodium

Sumatriptan And Naproxen Sodium

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

• Product ID: 16714-891_08e706b1-6ef6-467b-96d1-2439657861fe
• NDC: 16714-891
• Product Type: Human Prescription Drug
• Proprietary Name: Sumatriptan and Naproxen Sodium
• Generic Name: Sumatriptan And Naproxen Sodium
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-11-27
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202803
• Labeler Name: NorthStar RxLLC
• 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],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 16714-891-01

9 TABLET, FILM COATED in 1 BOTTLE (16714-891-01)

• Marketing Start Date: 2018-11-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 16714-891-01 [16714089101]

Sumatriptan and Naproxen Sodium TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA202803
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-11-27

Drug Details

Active Ingredients

Ingredient	Strength
SUMATRIPTAN SUCCINATE	85 mg/1

OpenFDA Data

• SPL SET ID: 3f2ec27e-0e96-4028-a1fa-114e6d501464
• Manufacturer:
  • NorthStar RxLLC
• UNII:
  • J8BDZ68989
  • 9TN87S3A3C
• RxNorm Concept Unique ID - RxCUI:
  • 849450
• UPC Code:
  • 0316714891019

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 "Sumatriptan and Naproxen Sodium" or generic name "Sumatriptan And Naproxen Sodium"

NDC	Brand Name	Generic Name
0378-8755	Sumatriptan and Naproxen Sodium	sumatriptan and naproxen sodium
16714-891	Sumatriptan and Naproxen Sodium	Sumatriptan and Naproxen Sodium
47335-410	Sumatriptan and Naproxen Sodium	Sumatriptan and Naproxen Sodium
65862-928	Sumatriptan and Naproxen Sodium	Sumatriptan and Naproxen Sodium
71800-901	Sumatriptan and Naproxen Sodium	Sumatriptan and Naproxen Sodium