NDC 46708-246

amantadine

Amantadine

amantadine is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Amantadine Hydrochloride.

• Product ID: 46708-246_2d607d4e-2e5b-41f0-be0f-dd2305f2d82b
• NDC: 46708-246
• Product Type: Human Prescription Drug
• Proprietary Name: amantadine
• Generic Name: Amantadine
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2017-06-22
• Marketing Category: ANDA / ANDA
• Application Number: ANDA208966
• Labeler Name: Alembic Pharmaceuticals Limited
• 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 46708-246-30

30 CAPSULE in 1 BOTTLE (46708-246-30)

• Marketing Start Date: 2017-06-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 46708-246-30 [46708024630]

amantadine CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA208966
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-06-22

NDC 46708-246-91 [46708024691]

amantadine CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA208966
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-06-22

NDC 46708-246-71 [46708024671]

amantadine CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA208966
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-06-22

NDC 46708-246-31 [46708024631]

amantadine CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA208966
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-06-22

Drug Details

Active Ingredients

Ingredient	Strength
AMANTADINE HYDROCHLORIDE	100 mg/1

OpenFDA Data

• SPL SET ID: d8887814-3e56-447e-8bc3-add1861e0cf7
• Manufacturer:
  • Alembic Pharmaceuticals Limited
• UNII:
  • M6Q1EO9TD0
• RxNorm Concept Unique ID - RxCUI:
  • 849389
• UPC Code:
  • 0346708246303

Pharmacological Class

• 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