amantadine hydrochloride

Generic: amantadine hydrochloride

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine hydrochloride
Generic Name amantadine hydrochloride
Labeler strides pharma science limited
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

amantadine hydrochloride 100 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-862
Product ID 64380-862_cd49441d-853e-4400-90bb-8e9e81d96b9f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211354
Listing Expiration 2026-12-31
Marketing Start 2022-12-01

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 64380862
Hyphenated Format 64380-862

Supplemental Identifiers

RxCUI
849389
UPC
0364380862062
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 ANDA211354 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (64380-862-06)
  • 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (64380-862-07)
source: ndc

Packages (2)

64380-862-06 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (64380-862-06) 64380-862-07 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (64380-862-07)

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": "cd49441d-853e-4400-90bb-8e9e81d96b9f", "openfda": {"upc": ["0364380862062"], "unii": ["M6Q1EO9TD0"], "rxcui": ["849389"], "spl_set_id": ["20dad861-6ad1-4660-b315-8af57b294175"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, LIQUID FILLED in 1 BOTTLE (64380-862-06)", "package_ndc": "64380-862-06", "marketing_start_date": "20221201"}, {"sample": false, "description": "500 CAPSULE, LIQUID FILLED in 1 BOTTLE (64380-862-07)", "package_ndc": "64380-862-07", "marketing_start_date": "20221201"}], "brand_name": "Amantadine Hydrochloride", "product_id": "64380-862_cd49441d-853e-4400-90bb-8e9e81d96b9f", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "64380-862", "generic_name": "Amantadine Hydrochloride", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amantadine Hydrochloride", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA211354", "marketing_category": "ANDA", "marketing_start_date": "20221201", "listing_expiration_date": "20261231"}