amantadine hcl

Generic: amantadine hydrochloride

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine hcl
Generic Name amantadine hydrochloride
Labeler avpak
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

amantadine hydrochloride 100 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-069
Product ID 50268-069_38566e1f-b7b1-540f-e063-6394a90a2760
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078720
Listing Expiration 2026-12-31
Marketing Start 2014-03-28

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 50268069
Hyphenated Format 50268-069

Supplemental Identifiers

RxCUI
849389
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 hydrochloride (source: ndc)
Application Number ANDA078720 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-069-15) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (50268-069-11)
source: ndc

Packages (1)

50268-069-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-069-15) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (50268-069-11)

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": "38566e1f-b7b1-540f-e063-6394a90a2760", "openfda": {"unii": ["M6Q1EO9TD0"], "rxcui": ["849389"], "spl_set_id": ["461e6444-189e-62ed-6c61-1c36a04459c6"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-069-15)  / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (50268-069-11)", "package_ndc": "50268-069-15", "marketing_start_date": "20140328"}], "brand_name": "Amantadine HCl", "product_id": "50268-069_38566e1f-b7b1-540f-e063-6394a90a2760", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "50268-069", "generic_name": "AMANTADINE HYDROCHLORIDE", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amantadine HCl", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA078720", "marketing_category": "ANDA", "marketing_start_date": "20140328", "listing_expiration_date": "20261231"}