amantadine hydrochloride

Generic: amantadine hydrochloride

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine hydrochloride
Generic Name amantadine hydrochloride
Labeler actavis pharma, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amantadine hydrochloride 100 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-4920
Product ID 0591-4920_67ce5a52-d507-4333-b0a0-b7177f896aec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208096
Marketing Start 2017-01-03
Marketing End 2026-06-30

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 05914920
Hyphenated Format 0591-4920

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 hydrochloride (source: ndc)
Generic Name amantadine hydrochloride (source: ndc)
Application Number ANDA208096 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0591-4920-01)
source: ndc

Packages (1)

0591-4920-01 100 TABLET in 1 BOTTLE (0591-4920-01)

Ingredients (1)

amantadine hydrochloride (100 mg/1)

Linked Drug Pages (1)

Amantadine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "67ce5a52-d507-4333-b0a0-b7177f896aec", "openfda": {"unii": ["M6Q1EO9TD0"], "rxcui": ["849395"], "spl_set_id": ["d9c9eaf7-dcc7-49c1-99d4-49f4dac3779f"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0591-4920-01)", "package_ndc": "0591-4920-01", "marketing_end_date": "20260630", "marketing_start_date": "20170103"}], "brand_name": "Amantadine Hydrochloride", "product_id": "0591-4920_67ce5a52-d507-4333-b0a0-b7177f896aec", "dosage_form": "TABLET", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "0591-4920", "generic_name": "Amantadine Hydrochloride", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amantadine Hydrochloride", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA208096", "marketing_category": "ANDA", "marketing_end_date": "20260630", "marketing_start_date": "20170103"}