NDC 70482-075

OSMOLEX ER

Amantadine

OSMOLEX ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Adamas Pharma, Llc. The primary component is Amantadine Hydrochloride.

• Product ID: 70482-075_8321bb20-293e-4848-b1be-3116bf9ca476
• NDC: 70482-075
• Product Type: Human Prescription Drug
• Proprietary Name: OSMOLEX ER
• Generic Name: Amantadine
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2018-06-01
• Marketing Category: NDA /
• Application Number: NDA209410
• Labeler Name: Adamas Pharma, LLC
• Substance Name: AMANTADINE HYDROCHLORIDE
• Active Ingredient Strength: 129 mg/1
• Pharm Classes: Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 70482-075-07

2 BLISTER PACK in 1 CARTON (70482-075-07) > 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

• Marketing Start Date: 2018-06-01
• NDC Exclude Flag: N
• Sample Package?: Y

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