FDA.reportPublic FDA data

Amantadine

Product NDC
46708-586
11-digit product format
467080586
Labeler code
46708
Product ID
46708-586_1ca812f6-6983-4d9a-b08e-a8f7e50054b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46708-586-312023-01-31C16284748780-1f386c64a-0811-0266-e053-dadaa90a7c1aAmantadine Hydrochloride Tablets Rx only
46708-586-712023-01-31C16284748780-1f386c64a-0811-0266-e053-dadaa90a7c1aAmantadine Hydrochloride Tablets Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-586-31Amantadine100 in 1 BOTTLETABLET1002
46708-586-71Amantadine500 in 1 BOTTLETABLET5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-586AMANTADINE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, Legacy NDC, 2 package rows20230131_48fa07c8-8b95-40d7-a0f5-132577dfb2c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849395amantadine HCl 100 MG Oral TabletPSN48fa07c8-8b95-40d7-a0f5-132577dfb2c82
849395amantadine hydrochloride 100 MG Oral TabletSCD48fa07c8-8b95-40d7-a0f5-132577dfb2c82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-586-3146708058631100 TABLET in 1 BOTTLE (46708-586-31) 100 tablet2020-10-200000-00-00NoNoCurrent
46708-586-7146708058671500 TABLET in 1 BOTTLE (46708-586-71) 500 tablet2020-10-200000-00-00NoNoCurrent