amantadine hydrochloride

Generic: amantadine hydrochloride

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine hydrochloride
Generic Name amantadine hydrochloride
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amantadine hydrochloride 100 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1452
Product ID 67046-1452_2d940d35-6a65-e494-e063-6394a90a9d16
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209035
Listing Expiration 2026-12-31
Marketing Start 2025-02-07

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 670461452
Hyphenated Format 67046-1452

Supplemental Identifiers

RxCUI
849395
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 ANDA209035 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1452-3)
source: ndc

Packages (1)

67046-1452-3 30 TABLET in 1 BLISTER PACK (67046-1452-3)

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": "2d940d35-6a65-e494-e063-6394a90a9d16", "openfda": {"unii": ["M6Q1EO9TD0"], "rxcui": ["849395"], "spl_set_id": ["2d94073b-c064-c280-e063-6294a90af145"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1452-3)", "package_ndc": "67046-1452-3", "marketing_start_date": "20250207"}], "brand_name": "Amantadine Hydrochloride", "product_id": "67046-1452_2d940d35-6a65-e494-e063-6394a90a9d16", "dosage_form": "TABLET", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "67046-1452", "generic_name": "Amantadine Hydrochloride", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amantadine Hydrochloride", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA209035", "marketing_category": "ANDA", "marketing_start_date": "20250207", "listing_expiration_date": "20261231"}