FDA.reportPublic FDA data

Amantadine Hydrochloride

Product NDC
42543-497
11-digit product format
425430497
Labeler code
42543
Product ID
42543-497_0b366abe-58d8-43b8-8d0e-3659aad1c4af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Inc.
Application
ANDA209035
Marketing category
ANDA
Marketing start
2017-08-04
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 Hydrochloride
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
42543-497-01Amantadine Hydrochloride100 in 1 BOTTLETABLET1008
42543-497-05Amantadine Hydrochloride500 in 1 BOTTLETABLET5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42543-497-01EA - Each42543-4974f226166-9372-474e-b3e4-31c9604d2efc12017-08-11
42543-497-05EA - Each42543-4976edda662-80e3-4934-aef0-41509aed2bab12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42543-497AMANTADINE HYDROCHLORIDE TABLET [STRIDES PHARMA INC.]7Current NDC, Legacy NDC, 2 package rows20240620_9a99bb98-82a4-4b9e-9216-554dade72a3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849395amantadine HCl 100 MG Oral TabletPSN9a99bb98-82a4-4b9e-9216-554dade72a3c8
849395amantadine hydrochloride 100 MG Oral TabletSCD9a99bb98-82a4-4b9e-9216-554dade72a3c8
849395amantadine HCl 100 MG Oral TabletPSN1211ebf4-3169-20ca-e063-6294a90aee4d4
849395amantadine hydrochloride 100 MG Oral TabletSCD1211ebf4-3169-20ca-e063-6294a90aee4d4
849395amantadine HCl 100 MG Oral TabletPSN2d94073b-c064-c280-e063-6294a90af1451
849395amantadine hydrochloride 100 MG Oral TabletSCD2d94073b-c064-c280-e063-6294a90af1451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42543-497-0142543049701100 TABLET in 1 BOTTLE (42543-497-01) 100 tablet2017-08-040000-00-00NoNoCurrent
42543-497-0542543049705500 TABLET in 1 BOTTLE (42543-497-05) 500 tablet2017-08-080000-00-00NoNoCurrent