amantadine

Generic: amantadine

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine
Generic Name amantadine
Labeler american health packaging
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

amantadine hydrochloride 100 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-422
Product ID 60687-422_1fa7387b-3149-96a2-e063-6394a90ad8aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208966
Listing Expiration 2026-12-31
Marketing Start 2019-05-01

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 60687422
Hyphenated Format 60687-422

Supplemental Identifiers

RxCUI
849389
UNII
M6Q1EO9TD0

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 (source: ndc)
Generic Name amantadine (source: ndc)
Application Number ANDA208966 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-422-01) / 1 CAPSULE in 1 BLISTER PACK (60687-422-11)
source: ndc

Packages (1)

60687-422-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-422-01) / 1 CAPSULE in 1 BLISTER PACK (60687-422-11)

Ingredients (1)

amantadine hydrochloride (100 mg/1)

Linked Drug Pages (1)

Amantadine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1fa7387b-3149-96a2-e063-6394a90ad8aa", "openfda": {"unii": ["M6Q1EO9TD0"], "rxcui": ["849389"], "spl_set_id": ["5119801d-a5cb-4adf-96b2-08cc3a0ba594"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-422-01)  / 1 CAPSULE in 1 BLISTER PACK (60687-422-11)", "package_ndc": "60687-422-01", "marketing_start_date": "20190521"}], "brand_name": "Amantadine", "product_id": "60687-422_1fa7387b-3149-96a2-e063-6394a90ad8aa", "dosage_form": "CAPSULE", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "60687-422", "generic_name": "Amantadine", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amantadine", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA208966", "marketing_category": "ANDA", "marketing_start_date": "20190501", "listing_expiration_date": "20261231"}