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 TABLET
Routes
ORAL
Active Ingredients

amantadine hydrochloride 100 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-0111
Product ID 0832-0111_45af44df-1a9b-32b6-e063-6394a90acdaf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076186
Marketing Start 2011-12-15
Marketing End 2028-02-29

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 08320111
Hyphenated Format 0832-0111

Supplemental Identifiers

RxCUI
849395
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 ANDA076186 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0832-0111-00)
  • 100 BLISTER PACK in 1 CARTON (0832-0111-03) / 1 TABLET in 1 BLISTER PACK (0832-0111-89)
  • 500 TABLET in 1 BOTTLE (0832-0111-50)
source: ndc

Packages (3)

0832-0111-00 100 TABLET in 1 BOTTLE (0832-0111-00) 0832-0111-03 100 BLISTER PACK in 1 CARTON (0832-0111-03) / 1 TABLET in 1 BLISTER PACK (0832-0111-89) 0832-0111-50 500 TABLET in 1 BOTTLE (0832-0111-50)

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": "45af44df-1a9b-32b6-e063-6394a90acdaf", "openfda": {"unii": ["M6Q1EO9TD0"], "rxcui": ["849395"], "spl_set_id": ["63d9d4aa-5f92-45b0-98d0-d6ec38b727cb"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0832-0111-00)", "package_ndc": "0832-0111-00", "marketing_end_date": "20280229", "marketing_start_date": "20111215"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0832-0111-03)  / 1 TABLET in 1 BLISTER PACK (0832-0111-89)", "package_ndc": "0832-0111-03", "marketing_end_date": "20260831", "marketing_start_date": "20170707"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0832-0111-50)", "package_ndc": "0832-0111-50", "marketing_end_date": "20280229", "marketing_start_date": "20111215"}], "brand_name": "Amantadine Hydrochloride", "product_id": "0832-0111_45af44df-1a9b-32b6-e063-6394a90acdaf", "dosage_form": "TABLET", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "0832-0111", "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": "ANDA076186", "marketing_category": "ANDA", "marketing_end_date": "20280229", "marketing_start_date": "20111215"}