FDA.reportPublic FDA data

Amantadine Hydrochloride

Product NDC
72162-2408
11-digit product format
721622408
Labeler code
72162
Product ID
72162-2408_00435c08-65c8-4eef-9a46-beb3760660ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209171
Marketing category
ANDA
Marketing start
2017-06-12
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 Hydrochloride
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
72162-2408-1Amantadine Hydrochloride100 in 1 BOTTLECAPSULE100101
72162-2408-5Amantadine Hydrochloride500 in 1 BOTTLECAPSULE500101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2408-1EA - Each72162-24080c6d959e-668a-4318-8f1d-90f26b8de58712024-12-10
72162-2408-5EA - Each72162-2408cb1535a2-40d7-4c38-866c-6f7459f6443412024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2408AMANTADINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20241105_1f3c7c37-c488-4a88-8251-7db52dc03827.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSN1f3c7c37-c488-4a88-8251-7db52dc03827101
849389amantadine hydrochloride 100 MG Oral CapsuleSCD1f3c7c37-c488-4a88-8251-7db52dc03827101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2408-172162240801100 CAPSULE in 1 BOTTLE (72162-2408-1) 100 capsule2024-10-30NoNoCurrent
72162-2408-572162240805500 CAPSULE in 1 BOTTLE (72162-2408-5) 500 capsule2024-10-30NoNoCurrent