amantadine hydrochloride

Generic: amantadine hydrochloride

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine hydrochloride
Generic Name amantadine hydrochloride
Labeler upsher-smith laboratories, llc
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

amantadine hydrochloride 100 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-1015
Product ID 0832-1015_398493aa-8a67-10e2-e063-6394a90aef8d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070589
Marketing Start 2011-09-15
Marketing End 2026-12-31

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 08321015
Hyphenated Format 0832-1015

Supplemental Identifiers

RxCUI
849389
UPC
0308321015001
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 ANDA070589 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE, GELATIN COATED in 1 BOTTLE (0832-1015-00)
  • 500 CAPSULE, GELATIN COATED in 1 BOTTLE (0832-1015-50)
source: ndc

Packages (2)

0832-1015-00 100 CAPSULE, GELATIN COATED in 1 BOTTLE (0832-1015-00) 0832-1015-50 500 CAPSULE, GELATIN COATED in 1 BOTTLE (0832-1015-50)

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": "398493aa-8a67-10e2-e063-6394a90aef8d", "openfda": {"upc": ["0308321015001"], "unii": ["M6Q1EO9TD0"], "rxcui": ["849389"], "spl_set_id": ["5232b933-1df9-43b4-8ac2-61bfa4855e68"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, GELATIN COATED in 1 BOTTLE (0832-1015-00)", "package_ndc": "0832-1015-00", "marketing_end_date": "20261231", "marketing_start_date": "20110915"}, {"sample": false, "description": "500 CAPSULE, GELATIN COATED in 1 BOTTLE (0832-1015-50)", "package_ndc": "0832-1015-50", "marketing_end_date": "20261231", "marketing_start_date": "20110915"}], "brand_name": "Amantadine Hydrochloride", "product_id": "0832-1015_398493aa-8a67-10e2-e063-6394a90aef8d", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "0832-1015", "generic_name": "amantadine hydrochloride", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amantadine Hydrochloride", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA070589", "marketing_category": "ANDA", "marketing_end_date": "20261231", "marketing_start_date": "20110915"}