amantadine hydrochloride

Generic: amantadine hydrochloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine hydrochloride
Generic Name amantadine hydrochloride
Labeler rising pharma holdings, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

amantadine hydrochloride 100 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-834
Product ID 16571-834_1a920249-de25-4d4e-b515-4fcbf3ead399
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210129
Listing Expiration 2026-12-31
Marketing Start 2022-09-05

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 16571834
Hyphenated Format 16571-834

Supplemental Identifiers

RxCUI
849389
UPC
0316571834013 0316571834501
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 ANDA210129 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (16571-834-01)
  • 500 CAPSULE in 1 BOTTLE (16571-834-50)
source: ndc

Packages (2)

16571-834-01 100 CAPSULE in 1 BOTTLE (16571-834-01) 16571-834-50 500 CAPSULE in 1 BOTTLE (16571-834-50)

Ingredients (1)

amantadine hydrochloride (100 mg/1)

Linked Drug Pages (1)

Amantadine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1a920249-de25-4d4e-b515-4fcbf3ead399", "openfda": {"upc": ["0316571834013", "0316571834501"], "unii": ["M6Q1EO9TD0"], "rxcui": ["849389"], "spl_set_id": ["6fd54e00-a714-4442-af95-2515ab3b2ac3"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (16571-834-01)", "package_ndc": "16571-834-01", "marketing_start_date": "20220905"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (16571-834-50)", "package_ndc": "16571-834-50", "marketing_start_date": "20220905"}], "brand_name": "Amantadine Hydrochloride", "product_id": "16571-834_1a920249-de25-4d4e-b515-4fcbf3ead399", "dosage_form": "CAPSULE", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "16571-834", "generic_name": "Amantadine Hydrochloride", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amantadine Hydrochloride", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA210129", "marketing_category": "ANDA", "marketing_start_date": "20220905", "listing_expiration_date": "20261231"}