amantadine hydrochloride

Generic: amantadine hydrochloride

Labeler: strides pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine hydrochloride
Generic Name amantadine hydrochloride
Labeler strides pharma inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amantadine hydrochloride 100 mg/1

Manufacturer
Strides Pharma Inc.

Identifiers & Regulatory

Product NDC 42543-497
Product ID 42543-497_0b366abe-58d8-43b8-8d0e-3659aad1c4af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209035
Listing Expiration 2027-12-31
Marketing Start 2017-08-04

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 42543497
Hyphenated Format 42543-497

Supplemental Identifiers

RxCUI
849395
UPC
0342543497016
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 ANDA209035 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (42543-497-01)
  • 500 TABLET in 1 BOTTLE (42543-497-05)
source: ndc

Packages (2)

42543-497-01 100 TABLET in 1 BOTTLE (42543-497-01) 42543-497-05 500 TABLET in 1 BOTTLE (42543-497-05)

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": "0b366abe-58d8-43b8-8d0e-3659aad1c4af", "openfda": {"upc": ["0342543497016"], "unii": ["M6Q1EO9TD0"], "rxcui": ["849395"], "spl_set_id": ["9a99bb98-82a4-4b9e-9216-554dade72a3c"], "manufacturer_name": ["Strides Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42543-497-01)", "package_ndc": "42543-497-01", "marketing_start_date": "20170804"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (42543-497-05)", "package_ndc": "42543-497-05", "marketing_start_date": "20170808"}], "brand_name": "Amantadine Hydrochloride", "product_id": "42543-497_0b366abe-58d8-43b8-8d0e-3659aad1c4af", "dosage_form": "TABLET", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "42543-497", "generic_name": "Amantadine Hydrochloride", "labeler_name": "Strides Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amantadine Hydrochloride", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA209035", "marketing_category": "ANDA", "marketing_start_date": "20170804", "listing_expiration_date": "20271231"}