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 SOLUTION
Routes
ORAL
Active Ingredients

amantadine hydrochloride 50 mg/5mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-010
Product ID 62135-010_45c62a1b-f162-d3cb-e063-6394a90a7dbf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074028
Listing Expiration 2026-12-31
Marketing Start 1993-06-28

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 62135010
Hyphenated Format 62135-010

Supplemental Identifiers

RxCUI
849385
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 ANDA074028 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (62135-010-47)
source: ndc

Packages (1)

62135-010-47 473 mL in 1 BOTTLE (62135-010-47)

Ingredients (1)

amantadine hydrochloride (50 mg/5mL)

Linked Drug Pages (1)

Amantadine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "45c62a1b-f162-d3cb-e063-6394a90a7dbf", "openfda": {"unii": ["M6Q1EO9TD0"], "rxcui": ["849385"], "spl_set_id": ["52aa093c-82cc-4d81-b072-86a2b8adc9c5"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (62135-010-47)", "package_ndc": "62135-010-47", "marketing_start_date": "20221213"}], "brand_name": "Amantadine Hydrochloride", "product_id": "62135-010_45c62a1b-f162-d3cb-e063-6394a90a7dbf", "dosage_form": "SOLUTION", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "62135-010", "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": "50 mg/5mL"}], "application_number": "ANDA074028", "marketing_category": "ANDA", "marketing_start_date": "19930628", "listing_expiration_date": "20261231"}