amantadine hydrochloride

Generic: amantadine hydrochloride

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine hydrochloride
Generic Name amantadine hydrochloride
Labeler cardinal health 107, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

amantadine hydrochloride 50 mg/5mL

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-9444
Product ID 55154-9444_6c7a0b3e-eb0d-422a-b4c9-64267e364aef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074509
Listing Expiration 2026-12-31
Marketing Start 1995-07-17

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 551549444
Hyphenated Format 55154-9444

Supplemental Identifiers

RxCUI
849385
UPC
0055154944458
UNII
M6Q1EO9TD0

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 ANDA074509 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/5mL
source: ndc
Packaging
  • 5 CUP, UNIT-DOSE in 1 BAG (55154-9444-5) / 10 mL in 1 CUP, UNIT-DOSE
source: ndc

Packages (1)

55154-9444-5 5 CUP, UNIT-DOSE in 1 BAG (55154-9444-5) / 10 mL in 1 CUP, UNIT-DOSE

Ingredients (1)

amantadine hydrochloride (50 mg/5mL)

Linked Drug Pages (1)

AMANTADINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6c7a0b3e-eb0d-422a-b4c9-64267e364aef", "openfda": {"upc": ["0055154944458"], "unii": ["M6Q1EO9TD0"], "rxcui": ["849385"], "spl_set_id": ["5989098d-2855-4b5f-9a06-64a83656c078"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "5 CUP, UNIT-DOSE in 1 BAG (55154-9444-5)  / 10 mL in 1 CUP, UNIT-DOSE", "package_ndc": "55154-9444-5", "marketing_start_date": "19950717"}], "brand_name": "AMANTADINE HYDROCHLORIDE", "product_id": "55154-9444_6c7a0b3e-eb0d-422a-b4c9-64267e364aef", "dosage_form": "SOLUTION", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "55154-9444", "generic_name": "AMANTADINE HYDROCHLORIDE", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMANTADINE HYDROCHLORIDE", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "50 mg/5mL"}], "application_number": "ANDA074509", "marketing_category": "ANDA", "marketing_start_date": "19950717", "listing_expiration_date": "20261231"}