amantadine hydrochloride

Generic: amantadine hydrochloride

Labeler: epic pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine hydrochloride
Generic Name amantadine hydrochloride
Labeler epic pharma llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

amantadine hydrochloride 100 mg/1

Manufacturer
EPIC PHARMA LLC

Identifiers & Regulatory

Product NDC 42806-716
Product ID 42806-716_1497ce1d-a997-4828-a08d-3f93653a88d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214580
Listing Expiration 2026-12-31
Marketing Start 2021-06-17

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 42806716
Hyphenated Format 42806-716

Supplemental Identifiers

RxCUI
849389
UPC
0342806716052
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 ANDA214580 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (42806-716-05)
  • 10 CAPSULE in 1 BOTTLE (42806-716-11)
source: ndc

Packages (2)

42806-716-05 500 CAPSULE in 1 BOTTLE (42806-716-05) 42806-716-11 10 CAPSULE in 1 BOTTLE (42806-716-11)

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": "1497ce1d-a997-4828-a08d-3f93653a88d5", "openfda": {"upc": ["0342806716052"], "unii": ["M6Q1EO9TD0"], "rxcui": ["849389"], "spl_set_id": ["0f70c79a-92a4-4a38-bbdd-900adc4c2e93"], "manufacturer_name": ["EPIC PHARMA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE (42806-716-05)", "package_ndc": "42806-716-05", "marketing_start_date": "20210617"}, {"sample": false, "description": "10 CAPSULE in 1 BOTTLE (42806-716-11)", "package_ndc": "42806-716-11", "marketing_start_date": "20210617"}], "brand_name": "amantadine hydrochloride", "product_id": "42806-716_1497ce1d-a997-4828-a08d-3f93653a88d5", "dosage_form": "CAPSULE", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "42806-716", "generic_name": "amantadine hydrochloride", "labeler_name": "EPIC PHARMA LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "amantadine hydrochloride", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA214580", "marketing_category": "ANDA", "marketing_start_date": "20210617", "listing_expiration_date": "20261231"}