amantadine hydrochloride

Generic: amantadine hydrochloride

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine hydrochloride
Generic Name amantadine hydrochloride
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

amantadine hydrochloride 100 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 68382-512
Product ID 68382-512_6e270f1c-83bd-4c12-a810-69f7c797fd61
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208278
Listing Expiration 2026-12-31
Marketing Start 2016-08-04

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 68382512
Hyphenated Format 68382-512

Supplemental Identifiers

RxCUI
849389
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 ANDA208278 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (68382-512-01)
  • 500 CAPSULE in 1 BOTTLE (68382-512-05)
  • 30 CAPSULE in 1 BOTTLE (68382-512-06)
  • 10 BLISTER PACK in 1 CARTON (68382-512-77) / 10 CAPSULE in 1 BLISTER PACK (68382-512-30)
source: ndc

Packages (4)

68382-512-01 100 CAPSULE in 1 BOTTLE (68382-512-01) 68382-512-05 500 CAPSULE in 1 BOTTLE (68382-512-05) 68382-512-06 30 CAPSULE in 1 BOTTLE (68382-512-06) 68382-512-77 10 BLISTER PACK in 1 CARTON (68382-512-77) / 10 CAPSULE in 1 BLISTER PACK (68382-512-30)

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": "6e270f1c-83bd-4c12-a810-69f7c797fd61", "openfda": {"unii": ["M6Q1EO9TD0"], "rxcui": ["849389"], "spl_set_id": ["609dc911-1e9d-4ebd-b64b-f44054e5582e"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68382-512-01)", "package_ndc": "68382-512-01", "marketing_start_date": "20160804"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (68382-512-05)", "package_ndc": "68382-512-05", "marketing_start_date": "20160804"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68382-512-06)", "package_ndc": "68382-512-06", "marketing_start_date": "20160804"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-512-77)  / 10 CAPSULE in 1 BLISTER PACK (68382-512-30)", "package_ndc": "68382-512-77", "marketing_start_date": "20160804"}], "brand_name": "amantadine hydrochloride", "product_id": "68382-512_6e270f1c-83bd-4c12-a810-69f7c797fd61", "dosage_form": "CAPSULE", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "68382-512", "generic_name": "amantadine hydrochloride", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "amantadine hydrochloride", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA208278", "marketing_category": "ANDA", "marketing_start_date": "20160804", "listing_expiration_date": "20261231"}