Amantadine HCL

Product NDC
72189-412
11-digit product format
721890412
Labeler code
72189
Product ID
72189-412_2c4cfb73-b3b1-daf3-e063-6294a90af289
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA209047
Marketing category
ANDA
Marketing start
2023-01-18
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amantadine HCL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMANTADINE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM6Q1EO9TD0
Rxcui849389

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
72189-412-30Amantadine HCL30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-412-30EA - Each72189-412c687f519-1d70-4e7a-b08d-5f264efc18fc12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-412AMANTADINE HCL CAPSULE [DIRECT_RX]4Current NDC, 1 package rows20250123_f28c55c8-2754-a44d-e053-2a95a90ae798.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSNf28c55c8-2754-a44d-e053-2a95a90ae7984
849389amantadine hydrochloride 100 MG Oral CapsuleSCDf28c55c8-2754-a44d-e053-2a95a90ae7984

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-412-307218904123030 CAPSULE in 1 BOTTLE (72189-412-30) 30 capsule2023-01-18NoNoCurrent