amantadine hydrochloride

Generic: amantadine hydrochloride

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine hydrochloride
Generic Name amantadine hydrochloride
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

amantadine hydrochloride 100 mg/1

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-362
Product ID 23155-362_fc8e4e42-8e97-41f0-aefc-2f01f65d8c6b
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 23155362
Hyphenated Format 23155-362

Supplemental Identifiers

RxCUI
849389
UPC
0323155362039
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
  • 100 CAPSULE in 1 BOTTLE (23155-362-01)
  • 30 CAPSULE in 1 BOTTLE (23155-362-03)
  • 500 CAPSULE in 1 BOTTLE (23155-362-05)
source: ndc

Packages (3)

23155-362-01 100 CAPSULE in 1 BOTTLE (23155-362-01) 23155-362-03 30 CAPSULE in 1 BOTTLE (23155-362-03) 23155-362-05 500 CAPSULE in 1 BOTTLE (23155-362-05)

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": "fc8e4e42-8e97-41f0-aefc-2f01f65d8c6b", "openfda": {"upc": ["0323155362039"], "unii": ["M6Q1EO9TD0"], "rxcui": ["849389"], "spl_set_id": ["1b9498b7-125e-4314-baca-b62af6e5511c"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (23155-362-01)", "package_ndc": "23155-362-01", "marketing_start_date": "20170612"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (23155-362-03)", "package_ndc": "23155-362-03", "marketing_start_date": "20170612"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (23155-362-05)", "package_ndc": "23155-362-05", "marketing_start_date": "20170612"}], "brand_name": "Amantadine Hydrochloride", "product_id": "23155-362_fc8e4e42-8e97-41f0-aefc-2f01f65d8c6b", "dosage_form": "CAPSULE", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "23155-362", "generic_name": "Amantadine Hydrochloride", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "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"}