amantadine hcl

Generic: amantadine hcl

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine hcl
Generic Name amantadine hcl
Labeler direct_rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amantadine hydrochloride 100 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-535
Product ID 72189-535_12894d87-0c1f-831b-e063-6294a90af11d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209035
Listing Expiration 2026-12-31
Marketing Start 2024-02-23

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 72189535
Hyphenated Format 72189-535

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 hcl (source: ndc)
Generic Name amantadine hcl (source: ndc)
Application Number ANDA209035 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (72189-535-30)
  • 90 TABLET in 1 BOTTLE (72189-535-90)
source: ndc

Packages (2)

72189-535-30 30 TABLET in 1 BOTTLE (72189-535-30) 72189-535-90 90 TABLET in 1 BOTTLE (72189-535-90)

Ingredients (1)

amantadine hydrochloride (100 mg/1)

Linked Drug Pages (1)

Amantadine HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "12894d87-0c1f-831b-e063-6294a90af11d", "openfda": {"unii": ["M6Q1EO9TD0"], "rxcui": ["849395"], "spl_set_id": ["1211ebf4-3169-20ca-e063-6294a90aee4d"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-535-30)", "package_ndc": "72189-535-30", "marketing_start_date": "20240223"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (72189-535-90)", "package_ndc": "72189-535-90", "marketing_start_date": "20240223"}], "brand_name": "Amantadine HCL", "product_id": "72189-535_12894d87-0c1f-831b-e063-6294a90af11d", "dosage_form": "TABLET", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "72189-535", "generic_name": "Amantadine HCL", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amantadine HCL", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA209035", "marketing_category": "ANDA", "marketing_start_date": "20240223", "listing_expiration_date": "20261231"}