amantadine hydrochloride

Generic: amantadine hydrochloride

Labeler: chartwell governmental & specialty rx, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine hydrochloride
Generic Name amantadine hydrochloride
Labeler chartwell governmental & specialty rx, llc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

amantadine hydrochloride 100 mg/10mL

Manufacturer
Chartwell Governmental & Specialty RX, LLC.

Identifiers & Regulatory

Product NDC 68999-011
Product ID 68999-011_4651addb-4284-88e1-e063-6294a90a3d13
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074028
Listing Expiration 2026-12-31
Marketing Start 1993-06-28

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 68999011
Hyphenated Format 68999-011

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 ANDA074028 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/10mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (68999-011-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68999-011-59)
source: ndc

Packages (1)

68999-011-24 2 TRAY in 1 BOX (68999-011-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68999-011-59)

Ingredients (1)

amantadine hydrochloride (100 mg/10mL)

Linked Drug Pages (1)

Amantadine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4651addb-4284-88e1-e063-6294a90a3d13", "openfda": {"unii": ["M6Q1EO9TD0"], "rxcui": ["849385"], "spl_set_id": ["3c448cb3-7996-4a83-a9ad-23a00a431fbe"], "manufacturer_name": ["Chartwell Governmental & Specialty RX, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (68999-011-24)  / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68999-011-59)", "package_ndc": "68999-011-24", "marketing_start_date": "20251217"}], "brand_name": "Amantadine Hydrochloride", "product_id": "68999-011_4651addb-4284-88e1-e063-6294a90a3d13", "dosage_form": "SOLUTION", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "68999-011", "generic_name": "Amantadine Hydrochloride", "labeler_name": "Chartwell Governmental & Specialty RX, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amantadine Hydrochloride", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "100 mg/10mL"}], "application_number": "ANDA074028", "marketing_category": "ANDA", "marketing_start_date": "19930628", "listing_expiration_date": "20261231"}