Amantadine

Product NDC
82804-267
11-digit product format
828040267
Labeler code
82804
Product ID
82804-267_7aa6bc18-1cee-4b6d-b7c3-0bac6a924ece
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA214284
Marketing category
ANDA
Marketing start
2020-10-20
Substance
AMANTADINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amantadine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMANTADINE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM6Q1EO9TD0
Rxcui849395

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
519d6abc-639d-2962-cced-abbf8b16aad4Product name720250401
82f46845-b4c7-48da-a389-ba5721b956c9Product name220250325
d2c037c0-5ebf-d224-252f-2549922c21c7Product name720240208
b7b57a62-2f7f-1a22-2cb2-eaa5c08d4721Product name220220224
14e11aaf-885f-472f-a02a-c6a3f28df907Product name120180515
82f46845-b4c7-48da-a389-ba5721b956c9Product name120171103

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82804-267-20Amantadine20 in 1 BOTTLETABLET201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849395amantadine HCl 100 MG Oral TabletPSN7aa6bc18-1cee-4b6d-b7c3-0bac6a924ece1
849395amantadine hydrochloride 100 MG Oral TabletSCD7aa6bc18-1cee-4b6d-b7c3-0bac6a924ece1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-267-208280402672020 TABLET in 1 BOTTLE (82804-267-20) 20 tablet2026-02-18NoNoCurrent