amantadine hydrochloride

Generic: amantadine hydrochloride

Labeler: atlantic biologicals corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine hydrochloride
Generic Name amantadine hydrochloride
Labeler atlantic biologicals corp.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

amantadine hydrochloride 50 mg/5mL

Manufacturer
ATLANTIC BIOLOGICALS CORP.

Identifiers & Regulatory

Product NDC 17856-0646
Product ID 17856-0646_34f3552c-a90d-da9a-e063-6294a90a65a3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074509
Listing Expiration 2026-12-31
Marketing Start 1995-07-17

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 178560646
Hyphenated Format 17856-0646

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
  • 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0646-1) / 10 mL in 1 CUP, UNIT-DOSE (17856-0646-3)
  • 72 CUP, UNIT-DOSE in 1 PACKAGE (17856-0646-2) / 5 mL in 1 CUP, UNIT-DOSE (17856-0646-4)
source: ndc

Packages (2)

17856-0646-1 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0646-1) / 10 mL in 1 CUP, UNIT-DOSE (17856-0646-3) 17856-0646-2 72 CUP, UNIT-DOSE in 1 PACKAGE (17856-0646-2) / 5 mL in 1 CUP, UNIT-DOSE (17856-0646-4)

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": "34f3552c-a90d-da9a-e063-6294a90a65a3", "openfda": {"unii": ["M6Q1EO9TD0"], "rxcui": ["849385"], "spl_set_id": ["6311b46b-23cc-40c1-93c2-f7c92606386f"], "manufacturer_name": ["ATLANTIC BIOLOGICALS CORP."]}, "finished": true, "packaging": [{"sample": false, "description": "72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0646-1)  / 10 mL in 1 CUP, UNIT-DOSE (17856-0646-3)", "package_ndc": "17856-0646-1", "marketing_start_date": "20240408"}, {"sample": false, "description": "72 CUP, UNIT-DOSE in 1 PACKAGE (17856-0646-2)  / 5 mL in 1 CUP, UNIT-DOSE (17856-0646-4)", "package_ndc": "17856-0646-2", "marketing_start_date": "20240408"}], "brand_name": "AMANTADINE HYDROCHLORIDE", "product_id": "17856-0646_34f3552c-a90d-da9a-e063-6294a90a65a3", "dosage_form": "SOLUTION", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "17856-0646", "generic_name": "AMANTADINE HYDROCHLORIDE", "labeler_name": "ATLANTIC BIOLOGICALS CORP.", "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": "19950717", "listing_expiration_date": "20261231"}