amantadine hydrochloride

Generic: amantadine hydrochloride

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine hydrochloride
Generic Name amantadine hydrochloride
Labeler chartwell rx, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

amantadine hydrochloride 100 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-609
Product ID 62135-609_2424250c-0ccb-d7b0-e063-6394a90a63b7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209171
Listing Expiration 2026-12-31
Marketing Start 2017-06-12

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 62135609
Hyphenated Format 62135-609

Supplemental Identifiers

RxCUI
849389
UPC
0362135609900
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 ANDA209171 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (62135-609-90)
source: ndc

Packages (1)

62135-609-90 90 CAPSULE in 1 BOTTLE (62135-609-90)

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": "2424250c-0ccb-d7b0-e063-6394a90a63b7", "openfda": {"upc": ["0362135609900"], "unii": ["M6Q1EO9TD0"], "rxcui": ["849389"], "spl_set_id": ["a016ab57-d18f-4a3b-b2ab-f91fecc1eef7"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (62135-609-90)", "package_ndc": "62135-609-90", "marketing_start_date": "20230629"}], "brand_name": "Amantadine Hydrochloride", "product_id": "62135-609_2424250c-0ccb-d7b0-e063-6394a90a63b7", "dosage_form": "CAPSULE", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "62135-609", "generic_name": "Amantadine Hydrochloride", "labeler_name": "Chartwell RX, LLC", "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": "20170612", "listing_expiration_date": "20261231"}