NDC 0378-8755

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 Mylan Pharmaceuticals Inc.. The primary component is Sumatriptan Succinate; Naproxen Sodium.

• Product ID: 0378-8755_27fc4438-dd5f-4fe6-a99d-f447f66a5a46
• NDC: 0378-8755
• 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: 2018-09-04
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090872
• Labeler Name: Mylan Pharmaceuticals Inc.
• 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: 2021-12-31

Packaging

NDC 0378-8755-59

9 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-8755-59)

• Marketing Start Date: 2018-09-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-8755-59 [00378875559]

Sumatriptan and Naproxen Sodium TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA090872
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-09-04

Drug Details

Active Ingredients

Ingredient	Strength
SUMATRIPTAN SUCCINATE	85 mg/1

OpenFDA Data

• SPL SET ID: 16cda517-6c19-467e-b8cc-e603f2e06fb9
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • J8BDZ68989
  • 9TN87S3A3C
• RxNorm Concept Unique ID - RxCUI:
  • 849450
• UPC Code:
  • 0303788755590

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]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]

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