amantadine hydrochloride

Generic: amantadine hydrochloride

Labeler: advagen pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine hydrochloride
Generic Name amantadine hydrochloride
Labeler advagen pharma limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

amantadine hydrochloride 100 mg/1

Manufacturer
Advagen Pharma Limited

Identifiers & Regulatory

Product NDC 72888-033
Product ID 72888-033_3982396f-63e5-ca93-e063-6394a90a75f2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212044
Listing Expiration 2026-12-31
Marketing Start 2020-05-21

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 72888033
Hyphenated Format 72888-033

Supplemental Identifiers

RxCUI
849389
UPC
0372888033051 0372888033303 0372888033013 0372888033006
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 ANDA212044 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1000 CAPSULE in 1 BOTTLE (72888-033-00)
  • 100 CAPSULE in 1 BOTTLE (72888-033-01)
  • 500 CAPSULE in 1 BOTTLE (72888-033-05)
  • 30 CAPSULE in 1 BOTTLE (72888-033-30)
source: ndc

Packages (4)

72888-033-00 1000 CAPSULE in 1 BOTTLE (72888-033-00) 72888-033-01 100 CAPSULE in 1 BOTTLE (72888-033-01) 72888-033-05 500 CAPSULE in 1 BOTTLE (72888-033-05) 72888-033-30 30 CAPSULE in 1 BOTTLE (72888-033-30)

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": "3982396f-63e5-ca93-e063-6394a90a75f2", "openfda": {"upc": ["0372888033051", "0372888033303", "0372888033013", "0372888033006"], "unii": ["M6Q1EO9TD0"], "rxcui": ["849389"], "spl_set_id": ["c3b9e7f0-be6d-4f37-9277-54bb0ba8b158"], "manufacturer_name": ["Advagen Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (72888-033-00)", "package_ndc": "72888-033-00", "marketing_start_date": "20200521"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (72888-033-01)", "package_ndc": "72888-033-01", "marketing_start_date": "20200521"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (72888-033-05)", "package_ndc": "72888-033-05", "marketing_start_date": "20200521"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (72888-033-30)", "package_ndc": "72888-033-30", "marketing_start_date": "20200521"}], "brand_name": "Amantadine Hydrochloride", "product_id": "72888-033_3982396f-63e5-ca93-e063-6394a90a75f2", "dosage_form": "CAPSULE", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "72888-033", "generic_name": "Amantadine Hydrochloride", "labeler_name": "Advagen Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amantadine Hydrochloride", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA212044", "marketing_category": "ANDA", "marketing_start_date": "20200521", "listing_expiration_date": "20261231"}