NDC 60687-422

Amantadine

Amantadine

Amantadine is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by American Health Packaging. The primary component is Amantadine Hydrochloride.

• Product ID: 60687-422_849c8cb5-2205-3db6-e053-2991aa0a0357
• NDC: 60687-422
• Product Type: Human Prescription Drug
• Proprietary Name: Amantadine
• Generic Name: Amantadine
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2019-04-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA208966
• Labeler Name: American Health Packaging
• Substance Name: AMANTADINE HYDROCHLORIDE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 60687-422-01

100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-422-01) > 1 CAPSULE in 1 BLISTER PACK (60687-422-11)

• Marketing Start Date: 2019-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 60687-422-11 [60687042211]

Amantadine CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA208966
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-04-01

NDC 60687-422-01 [60687042201]

Amantadine CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA208966
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-04-01

Drug Details

Active Ingredients

Ingredient	Strength
AMANTADINE HYDROCHLORIDE	100 mg/1

OpenFDA Data

• SPL SET ID: 5119801d-a5cb-4adf-96b2-08cc3a0ba594
• Manufacturer:
  • American Health Packaging
• UNII:
  • M6Q1EO9TD0
• RxNorm Concept Unique ID - RxCUI:
  • 849389

Pharmacological Class

• Influenza A M2 Protein Inhibitor [EPC]
• M2 Protein Inhibitors [MoA]
• Influenza A M2 Protein Inhibitor [EPC]
• M2 Protein Inhibitors [MoA]

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

NDC	Brand Name	Generic Name
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
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