NDC 68025-074

Osmolex ER

Amantadine

Osmolex ER is a Kit in the Human Prescription Drug category. It is labeled and distributed by Vertical Pharmaceuticals, Llc. The primary component is .

• Product ID: 68025-074_388c7510-ebf6-4cd4-bf4f-f19e23f9d667
• NDC: 68025-074
• Product Type: Human Prescription Drug
• Proprietary Name: Osmolex ER
• Generic Name: Amantadine
• Dosage Form: Kit
• Marketing Start Date: 2018-06-01
• Marketing Category: NDA / NDA
• Application Number: NDA209410
• Labeler Name: Vertical Pharmaceuticals, LLC
• Active Ingredient Strength: 0
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 68025-074-62

1 KIT in 1 CARTON (68025-074-62) * 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-075-30) * 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-076-30)

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

NDC SPL Data Element Entries

NDC 68025-074-62 [68025007462]

Osmolex ER KIT

• Marketing Category: NDA
• Application Number: NDA209410
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-06-01

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