FDA.reportPublic FDA data

Amantadine

Product NDC
62332-586
11-digit product format
623320586
Labeler code
62332
Product ID
62332-586_a9507ffa-0c95-48ce-80bf-60bc699add17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
62332-586-31Amantadine100 in 1 BOTTLETABLET1009
62332-586-71Amantadine500 in 1 BOTTLETABLET5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-586-31EA - Each62332-5860600aa84-6edf-465a-a9a6-bcd8b3a8f0ef12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-586AMANTADINE TABLET [ALEMBIC PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 2 package rows20250417_da1837b5-fda2-48e0-91ba-d6eb2b991b55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849395amantadine HCl 100 MG Oral TabletPSNda1837b5-fda2-48e0-91ba-d6eb2b991b559
849395amantadine hydrochloride 100 MG Oral TabletSCDda1837b5-fda2-48e0-91ba-d6eb2b991b559
849395amantadine HCl 100 MG Oral TabletPSN2ff05131-f634-4688-86e9-9bc33a8d11c41
849395amantadine HCl 100 MG Oral TabletPSN303c5b9d-5761-9fcd-e063-6394a90a8a2b1
849395amantadine HCl 100 MG Oral TabletPSN7aa6bc18-1cee-4b6d-b7c3-0bac6a924ece1
849395amantadine hydrochloride 100 MG Oral TabletSCD2ff05131-f634-4688-86e9-9bc33a8d11c41
849395amantadine hydrochloride 100 MG Oral TabletSCD303c5b9d-5761-9fcd-e063-6394a90a8a2b1
849395amantadine hydrochloride 100 MG Oral TabletSCD7aa6bc18-1cee-4b6d-b7c3-0bac6a924ece1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-586-3162332058631100 TABLET in 1 BOTTLE (62332-586-31) 100 tablet2020-10-200000-00-00NoNoCurrent
62332-586-7162332058671500 TABLET in 1 BOTTLE (62332-586-71) 500 tablet2020-10-200000-00-00NoNoCurrent