amantadine hydrochloride

Generic: amantadine hydrochloride

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

Drug Facts

Product Profile

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

amantadine hydrochloride 50 mg/5mL

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-797
Product ID 60687-797_11e80915-df52-1580-e063-6394a90a67b1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074509
Listing Expiration 2026-12-31
Marketing Start 2024-02-26

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 60687797
Hyphenated Format 60687-797

Supplemental Identifiers

RxCUI
849385
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 hydrochloride (source: ndc)
Generic Name amantadine hydrochloride (source: ndc)
Application Number ANDA074509 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/5mL
source: ndc
Packaging
  • 10 TRAY in 1 CASE (60687-797-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-797-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-797-42)
source: ndc

Packages (1)

60687-797-56 10 TRAY in 1 CASE (60687-797-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-797-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-797-42)

Ingredients (1)

amantadine hydrochloride (50 mg/5mL)

Linked Drug Pages (1)

Amantadine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "11e80915-df52-1580-e063-6394a90a67b1", "openfda": {"unii": ["M6Q1EO9TD0"], "rxcui": ["849385"], "spl_set_id": ["5a8f16cc-e5d5-4097-8297-10c8166c7a0e"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (60687-797-56)  / 10 CUP, UNIT-DOSE in 1 TRAY (60687-797-48)  / 10 mL in 1 CUP, UNIT-DOSE (60687-797-42)", "package_ndc": "60687-797-56", "marketing_start_date": "20240226"}], "brand_name": "Amantadine Hydrochloride", "product_id": "60687-797_11e80915-df52-1580-e063-6394a90a67b1", "dosage_form": "SOLUTION", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "60687-797", "generic_name": "Amantadine Hydrochloride", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amantadine Hydrochloride", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "50 mg/5mL"}], "application_number": "ANDA074509", "marketing_category": "ANDA", "marketing_start_date": "20240226", "listing_expiration_date": "20261231"}