NDC 68025-021

Osmolex ER

Amantadine

Osmolex ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Vertical Pharmaceuticals, Llc. The primary component is Amantadine.

• Product ID: 68025-021_ce2e1a99-33cb-84e4-e053-2a95a90a71e6
• NDC: 68025-021
• Product Type: Human Prescription Drug
• Proprietary Name: Osmolex ER
• Generic Name: Amantadine
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2022-05-05
• Marketing End Date: 2023-06-30
• Marketing Category: NDA /
• Application Number: NDA209410
• Labeler Name: Vertical Pharmaceuticals, LLC
• Substance Name: AMANTADINE
• Active Ingredient Strength: 161 mg/1
• Pharm Classes: Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]
• NDC Exclude Flag: N

Packaging

NDC 68025-021-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-021-30)

• Marketing Start Date: 2022-05-05
• Marketing End Date: 2023-06-30
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

NDC Crossover Matching brand name "Osmolex ER" or generic name "Amantadine"

NDC	Brand Name	Generic Name
68025-021	Osmolex ER	amantadine
68025-074	Osmolex ER	amantadine
68025-075	Osmolex ER	amantadine
68025-076	Osmolex ER	amantadine
68025-077	Osmolex ER	amantadine
70482-075	OSMOLEX ER	amantadine
70482-076	OSMOLEX ER	amantadine
46708-246	amantadine	amantadine
46708-586	Amantadine	Amantadine
60687-422	Amantadine	Amantadine
62332-246	amantadine	amantadine
62332-586	Amantadine	Amantadine
70482-085	GOCOVRI	AMANTADINE
70482-170	GOCOVRI	AMANTADINE