Amantadine

Product NDC
60687-422
11-digit product format
606870422
Labeler code
60687
Product ID
60687-422_1fa7387b-3149-96a2-e063-6394a90ad8aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA208966
Marketing category
ANDA
Marketing start
2019-05-01
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
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
60687-422-01Amantadine100 in 1 BOX, UNIT-DOSECAPSULE1005
60687-422-11Amantadine1 in 1 BLISTER PACKCAPSULE15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-422-01EA - Each60687-422c9760103-8d4d-46a5-a468-8dab9cfada4812019-05-02
60687-422-11EA - Each60687-4221b181dd1-e404-41ab-a460-4fe13c6e01ca12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-422AMANTADINE CAPSULE [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 2 package rows20240822_5119801d-a5cb-4adf-96b2-08cc3a0ba594.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSN5119801d-a5cb-4adf-96b2-08cc3a0ba5945
849389amantadine hydrochloride 100 MG Oral CapsuleSCD5119801d-a5cb-4adf-96b2-08cc3a0ba5945

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-422-0160687042201100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-422-01) / 1 CAPSULE in 1 BLISTER PACK (60687-422-11) 100 blister pack2019-05-210000-00-00NoNoCurrent
60687-422-11606870422111 in 1 BLISTER PACKHistorical