amantadine

Generic: amantadine

Labeler: xttrium laboratories, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine
Generic Name amantadine
Labeler xttrium laboratories, inc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

amantadine hydrochloride 50 mg/5mL

Manufacturer
Xttrium Laboratories, Inc

Identifiers & Regulatory

Product NDC 0116-4010
Product ID 0116-4010_3479947d-22a8-67e8-e063-6294a90ae41c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075060
Listing Expiration 2027-12-31
Marketing Start 2024-11-05

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 01164010
Hyphenated Format 0116-4010

Supplemental Identifiers

RxCUI
849385
UPC
0001164010164
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
  • 473 mL in 1 BOTTLE (0116-4010-16)
  • 100 TRAY in 1 CASE (0116-4010-41) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4010-10)
source: ndc

Packages (2)

0116-4010-16 473 mL in 1 BOTTLE (0116-4010-16) 0116-4010-41 100 TRAY in 1 CASE (0116-4010-41) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4010-10)

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": "3479947d-22a8-67e8-e063-6294a90ae41c", "openfda": {"upc": ["0001164010164"], "unii": ["M6Q1EO9TD0"], "rxcui": ["849385"], "spl_set_id": ["25dd8a3c-6b11-2ea1-e063-6294a90a50cf"], "manufacturer_name": ["Xttrium Laboratories, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (0116-4010-16)", "package_ndc": "0116-4010-16", "marketing_start_date": "20241105"}, {"sample": false, "description": "100 TRAY in 1 CASE (0116-4010-41)  / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4010-10)", "package_ndc": "0116-4010-41", "marketing_start_date": "20241105"}], "brand_name": "Amantadine", "product_id": "0116-4010_3479947d-22a8-67e8-e063-6294a90ae41c", "dosage_form": "SOLUTION", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "0116-4010", "generic_name": "Amantadine", "labeler_name": "Xttrium Laboratories, Inc", "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": "20241105", "listing_expiration_date": "20271231"}