amantadine hydrochloride

Generic: amantadine hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine hydrochloride
Generic Name amantadine hydrochloride
Labeler proficient rx lp
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

amantadine hydrochloride 100 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-196
Product ID 82804-196_a3810649-1301-4332-85df-722b36867b1b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212044
Listing Expiration 2026-12-31
Marketing Start 2020-05-21

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 82804196
Hyphenated Format 82804-196

Supplemental Identifiers

RxCUI
849389
UPC
0382804196203
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 ANDA212044 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 20 CAPSULE in 1 BOTTLE (82804-196-20)
source: ndc

Packages (1)

82804-196-20 20 CAPSULE in 1 BOTTLE (82804-196-20)

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": "a3810649-1301-4332-85df-722b36867b1b", "openfda": {"upc": ["0382804196203"], "unii": ["M6Q1EO9TD0"], "rxcui": ["849389"], "spl_set_id": ["a3810649-1301-4332-85df-722b36867b1b"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "20 CAPSULE in 1 BOTTLE (82804-196-20)", "package_ndc": "82804-196-20", "marketing_start_date": "20250217"}], "brand_name": "Amantadine Hydrochloride", "product_id": "82804-196_a3810649-1301-4332-85df-722b36867b1b", "dosage_form": "CAPSULE", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "82804-196", "generic_name": "Amantadine Hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amantadine Hydrochloride", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA212044", "marketing_category": "ANDA", "marketing_start_date": "20200521", "listing_expiration_date": "20261231"}