amantadine

Generic: amantadine

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine
Generic Name amantadine
Labeler alembic pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amantadine hydrochloride 100 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-586
Product ID 46708-586_1ca812f6-6983-4d9a-b08e-a8f7e50054b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214284
Listing Expiration 2026-12-31
Marketing Start 2020-10-20

Pharmacologic Class

Classes
influenza a m2 protein inhibitor [epc] m2 protein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708586
Hyphenated Format 46708-586

Supplemental Identifiers

RxCUI
849395
UNII
M6Q1EO9TD0

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name amantadine (source: ndc)
Generic Name amantadine (source: ndc)
Application Number ANDA214284 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (46708-586-31)
  • 500 TABLET in 1 BOTTLE (46708-586-71)
source: ndc

Packages (2)

46708-586-31 100 TABLET in 1 BOTTLE (46708-586-31) 46708-586-71 500 TABLET in 1 BOTTLE (46708-586-71)

Ingredients (1)

amantadine hydrochloride (100 mg/1)

Linked Drug Pages (1)

Amantadine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1ca812f6-6983-4d9a-b08e-a8f7e50054b8", "openfda": {"unii": ["M6Q1EO9TD0"], "rxcui": ["849395"], "spl_set_id": ["48fa07c8-8b95-40d7-a0f5-132577dfb2c8"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (46708-586-31)", "package_ndc": "46708-586-31", "marketing_start_date": "20201020"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (46708-586-71)", "package_ndc": "46708-586-71", "marketing_start_date": "20201020"}], "brand_name": "Amantadine", "product_id": "46708-586_1ca812f6-6983-4d9a-b08e-a8f7e50054b8", "dosage_form": "TABLET", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "46708-586", "generic_name": "Amantadine", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amantadine", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA214284", "marketing_category": "ANDA", "marketing_start_date": "20201020", "listing_expiration_date": "20261231"}