amantadine hydrochloride

Generic: amantadine hydrochloride

Labeler: bajaj medical, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine hydrochloride
Generic Name amantadine hydrochloride
Labeler bajaj medical, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

amantadine hydrochloride 50 mg/5mL

Manufacturer
BAJAJ MEDICAL, LLC

Identifiers & Regulatory

Product NDC 61037-484
Product ID 61037-484_38fc829b-496d-024d-e063-6294a90a11b5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075819
Listing Expiration 2026-12-31
Marketing Start 2025-07-31

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 61037484
Hyphenated Format 61037-484

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 hydrochloride (source: ndc)
Generic Name amantadine hydrochloride (source: ndc)
Application Number ANDA075819 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (61037-484-03)
source: ndc

Packages (1)

61037-484-03 473 mL in 1 BOTTLE (61037-484-03)

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": "38fc829b-496d-024d-e063-6294a90a11b5", "openfda": {"unii": ["M6Q1EO9TD0"], "rxcui": ["849385"], "spl_set_id": ["38fccce5-1f1e-9350-e063-6394a90a045a"], "manufacturer_name": ["BAJAJ MEDICAL, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (61037-484-03)", "package_ndc": "61037-484-03", "marketing_start_date": "20250731"}], "brand_name": "AMANTADINE HYDROCHLORIDE", "product_id": "61037-484_38fc829b-496d-024d-e063-6294a90a11b5", "dosage_form": "SOLUTION", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "61037-484", "generic_name": "AMANTADINE HYDROCHLORIDE", "labeler_name": "BAJAJ MEDICAL, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMANTADINE HYDROCHLORIDE", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "50 mg/5mL"}], "application_number": "ANDA075819", "marketing_category": "ANDA", "marketing_start_date": "20250731", "listing_expiration_date": "20261231"}