amantadine hcl

Generic: amantadine hydrochloride

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

Drug Facts

Product Profile

Brand Name amantadine hcl
Generic Name amantadine hydrochloride
Labeler bionpharma inc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

amantadine hydrochloride 100 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-142
Product ID 69452-142_372af940-7fe9-4525-e063-6294a90ab417
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078720
Listing Expiration 2026-12-31
Marketing Start 2016-08-15

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 69452142
Hyphenated Format 69452-142

Supplemental Identifiers

RxCUI
849389
UPC
0369452142202
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 hcl (source: ndc)
Generic Name amantadine hydrochloride (source: ndc)
Application Number ANDA078720 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-142-20)
  • 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-142-30)
source: ndc

Packages (2)

69452-142-20 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-142-20) 69452-142-30 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-142-30)

Ingredients (1)

amantadine hydrochloride (100 mg/1)

Linked Drug Pages (1)

Amantadine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "372af940-7fe9-4525-e063-6294a90ab417", "openfda": {"upc": ["0369452142202"], "unii": ["M6Q1EO9TD0"], "rxcui": ["849389"], "spl_set_id": ["d6ca4d20-72c5-496c-9ac7-1f5cb407a742"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-142-20)", "package_ndc": "69452-142-20", "marketing_start_date": "20160815"}, {"sample": false, "description": "500 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-142-30)", "package_ndc": "69452-142-30", "marketing_start_date": "20160815"}], "brand_name": "Amantadine HCl", "product_id": "69452-142_372af940-7fe9-4525-e063-6294a90ab417", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "69452-142", "generic_name": "AMANTADINE HYDROCHLORIDE", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amantadine HCl", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA078720", "marketing_category": "ANDA", "marketing_start_date": "20160815", "listing_expiration_date": "20261231"}