amantadine hydrochloride

Generic: amantadine hydrochloride

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine hydrochloride
Generic Name amantadine hydrochloride
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

amantadine hydrochloride 100 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8263
Product ID 0615-8263_056d9ef2-8e38-40eb-8d3a-0d753e018030
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209171
Listing Expiration 2026-12-31
Marketing Start 2017-01-01

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 06158263
Hyphenated Format 0615-8263

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 hydrochloride (source: ndc)
Generic Name amantadine hydrochloride (source: ndc)
Application Number ANDA209171 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BLISTER PACK (0615-8263-39)
source: ndc

Packages (1)

0615-8263-39 30 CAPSULE in 1 BLISTER PACK (0615-8263-39)

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": "056d9ef2-8e38-40eb-8d3a-0d753e018030", "openfda": {"unii": ["M6Q1EO9TD0"], "rxcui": ["849389"], "spl_set_id": ["b54064bc-b3e1-4d83-be40-fcaddd2e99d0"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (0615-8263-39)", "package_ndc": "0615-8263-39", "marketing_start_date": "20190110"}], "brand_name": "Amantadine Hydrochloride", "product_id": "0615-8263_056d9ef2-8e38-40eb-8d3a-0d753e018030", "dosage_form": "CAPSULE", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "0615-8263", "generic_name": "Amantadine Hydrochloride", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amantadine Hydrochloride", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA209171", "marketing_category": "ANDA", "marketing_start_date": "20170101", "listing_expiration_date": "20261231"}