amantadine hydrochloride

Generic: amantadine hydrochloride

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine hydrochloride
Generic Name amantadine hydrochloride
Labeler pai holdings, llc dba pai pharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

amantadine hydrochloride 50 mg/5mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-0646
Product ID 0121-0646_0d5911e6-e5b6-4013-98ec-773d9ec62dec
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 01210646
Hyphenated Format 0121-0646

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 ANDA074509 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/5mL
source: ndc
Packaging
  • 10 TRAY in 1 CASE (0121-0646-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE
  • 473 mL in 1 BOTTLE (0121-0646-16)
source: ndc

Packages (2)

0121-0646-10 10 TRAY in 1 CASE (0121-0646-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE 0121-0646-16 473 mL in 1 BOTTLE (0121-0646-16)

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": "0d5911e6-e5b6-4013-98ec-773d9ec62dec", "openfda": {"unii": ["M6Q1EO9TD0"], "rxcui": ["849385"], "spl_set_id": ["be411327-5ac7-46df-b5e4-32a11b419b15"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (0121-0646-10)  / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE", "package_ndc": "0121-0646-10", "marketing_start_date": "19950717"}, {"sample": false, "description": "473 mL in 1 BOTTLE (0121-0646-16)", "package_ndc": "0121-0646-16", "marketing_start_date": "19950717"}], "brand_name": "AMANTADINE HYDROCHLORIDE", "product_id": "0121-0646_0d5911e6-e5b6-4013-98ec-773d9ec62dec", "dosage_form": "SOLUTION", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "0121-0646", "generic_name": "AMANTADINE HYDROCHLORIDE", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "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"}