FDA.reportPublic FDA data

Amantadine Hydrochloride

Product NDC
42543-493
11-digit product format
425430493
Labeler code
42543
Product ID
42543-493_20218de3-d4e9-4f7d-b1f5-bfb66e22420d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Strides Pharma Inc.
Application
ANDA209047
Marketing category
ANDA
Marketing start
2017-07-31
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
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
42543-493-01Amantadine Hydrochloride100 in 1 BOTTLECAPSULE10010
42543-493-05Amantadine Hydrochloride500 in 1 BOTTLECAPSULE50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42543-493-01EA - Each42543-49373638aa7-52ca-4aac-8cff-0b52fe02096a12017-08-11
42543-493-05EA - Each42543-49349fa98a3-70b9-42be-95af-0da9ab32917012017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42543-493AMANTADINE HYDROCHLORIDE CAPSULE [STRIDES PHARMA INC.]8Current NDC, Legacy NDC, 2 package rows20240420_e4d8f36f-d668-4728-8dca-b1c22bd9aedb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSN6326d7f5-4c7c-4541-8db1-c582f1525f60103
849389amantadine hydrochloride 100 MG Oral CapsuleSCD6326d7f5-4c7c-4541-8db1-c582f1525f60103
849389amantadine HCl 100 MG Oral CapsulePSNe4d8f36f-d668-4728-8dca-b1c22bd9aedb10
849389amantadine hydrochloride 100 MG Oral CapsuleSCDe4d8f36f-d668-4728-8dca-b1c22bd9aedb10
849389amantadine HCl 100 MG Oral CapsulePSNcdb39380-192f-480d-99a4-316f638d5cf25
849389amantadine hydrochloride 100 MG Oral CapsuleSCDcdb39380-192f-480d-99a4-316f638d5cf25
849389amantadine HCl 100 MG Oral CapsulePSNf28c55c8-2754-a44d-e053-2a95a90ae7984
849389amantadine hydrochloride 100 MG Oral CapsuleSCDf28c55c8-2754-a44d-e053-2a95a90ae7984
849389amantadine HCl 100 MG Oral CapsulePSNf0e9b795-c0a1-4c95-928c-dacaaf9b3bb52
849389amantadine hydrochloride 100 MG Oral CapsuleSCDf0e9b795-c0a1-4c95-928c-dacaaf9b3bb52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42543-493-0142543049301100 CAPSULE in 1 BOTTLE (42543-493-01) 100 capsule2017-07-310000-00-00NoNoCurrent
42543-493-0542543049305500 CAPSULE in 1 BOTTLE (42543-493-05) 500 capsule2017-07-310000-00-00NoNoCurrent