amantadine hydrochloride

Generic: amantadine hydrochloride

Labeler: marlex pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine hydrochloride
Generic Name amantadine hydrochloride
Labeler marlex pharmaceuticals inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amantadine hydrochloride 100 mg/1

Manufacturer
Marlex Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 10135-692
Product ID 10135-692_3e752827-026e-d525-e063-6394a90a7e80
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210215
Listing Expiration 2026-12-31
Marketing Start 2020-03-01

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 10135692
Hyphenated Format 10135-692

Supplemental Identifiers

RxCUI
849389 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 ANDA210215 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (10135-692-01)
  • 500 TABLET in 1 BOTTLE (10135-692-05)
source: ndc

Packages (2)

10135-692-01 100 TABLET in 1 BOTTLE (10135-692-01) 10135-692-05 500 TABLET in 1 BOTTLE (10135-692-05)

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": "3e752827-026e-d525-e063-6394a90a7e80", "openfda": {"unii": ["M6Q1EO9TD0"], "rxcui": ["849389", "849395"], "spl_set_id": ["25af52ee-9b29-4c07-a383-62d4537b63e0"], "manufacturer_name": ["Marlex Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (10135-692-01)", "package_ndc": "10135-692-01", "marketing_start_date": "20200301"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (10135-692-05)", "package_ndc": "10135-692-05", "marketing_start_date": "20200301"}], "brand_name": "Amantadine Hydrochloride", "product_id": "10135-692_3e752827-026e-d525-e063-6394a90a7e80", "dosage_form": "TABLET", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "10135-692", "generic_name": "Amantadine Hydrochloride", "labeler_name": "Marlex Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amantadine Hydrochloride", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA210215", "marketing_category": "ANDA", "marketing_start_date": "20200301", "listing_expiration_date": "20261231"}