amantadine

Generic: amantadine

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine
Generic Name amantadine
Labeler avpak
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

amantadine hydrochloride 50 mg/5mL

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-036
Product ID 50268-036_48c949ef-d92b-abba-e063-6394a90a2d2a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075060
Listing Expiration 2027-12-31
Marketing Start 2026-01-19

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 50268036
Hyphenated Format 50268-036

Supplemental Identifiers

RxCUI
849385
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 (source: ndc)
Generic Name amantadine (source: ndc)
Application Number ANDA075060 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/5mL
source: ndc
Packaging
  • 40 TRAY in 1 CASE (50268-036-14) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (50268-036-11)
source: ndc

Packages (1)

50268-036-14 40 TRAY in 1 CASE (50268-036-14) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (50268-036-11)

Ingredients (1)

amantadine hydrochloride (50 mg/5mL)

Linked Drug Pages (1)

Amantadine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48c949ef-d92b-abba-e063-6394a90a2d2a", "openfda": {"unii": ["M6Q1EO9TD0"], "rxcui": ["849385"], "spl_set_id": ["48c949e3-86e0-c639-e063-6294a90acdba"], "manufacturer_name": ["AvPAK"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "40 TRAY in 1 CASE (50268-036-14)  / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (50268-036-11)", "package_ndc": "50268-036-14", "marketing_start_date": "20260119"}], "brand_name": "Amantadine", "product_id": "50268-036_48c949ef-d92b-abba-e063-6394a90a2d2a", "dosage_form": "SOLUTION", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "50268-036", "generic_name": "Amantadine", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amantadine", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "50 mg/5mL"}], "application_number": "ANDA075060", "marketing_category": "ANDA", "marketing_start_date": "20260119", "listing_expiration_date": "20271231"}