FDA.reportPublic FDA data

Amantadine Hydrochloride

Product NDC
72888-033
11-digit product format
728880033
Labeler code
72888
Product ID
72888-033_3982396f-63e5-ca93-e063-6394a90a75f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Advagen Pharma Limited
Application
ANDA212044
Marketing category
ANDA
Marketing start
2020-05-21
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
72888-033-00Amantadine Hydrochloride1000 in 1 BOTTLECAPSULE10005
72888-033-01Amantadine Hydrochloride100 in 1 BOTTLECAPSULE1005
72888-033-05Amantadine Hydrochloride500 in 1 BOTTLECAPSULE5005
72888-033-30Amantadine Hydrochloride30 in 1 BOTTLECAPSULE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-033-01EA - Each72888-03313308d51-66f0-439a-b61d-a8c548f6771112021-04-08
72888-033-05EA - Each72888-0330cefca8e-1a39-4483-b717-c9d6c3a4804612021-12-08
72888-033-30EA - Each72888-033975d3aac-8e0c-4cca-b8b5-20474091e71a12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-033AMANTADINE HYDROCHLORIDE CAPSULE [ADVAGEN PHARMA LIMITED]4Current NDC, Legacy NDC, 4 package rows20211121_c3b9e7f0-be6d-4f37-9277-54bb0ba8b158.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSNc3b9e7f0-be6d-4f37-9277-54bb0ba8b1585
849389amantadine hydrochloride 100 MG Oral CapsuleSCDc3b9e7f0-be6d-4f37-9277-54bb0ba8b1585
849389amantadine HCl 100 MG Oral CapsulePSN56b923c3-1d4a-47bf-9c9e-c0fdc54c8a2f2
849389amantadine hydrochloride 100 MG Oral CapsuleSCD56b923c3-1d4a-47bf-9c9e-c0fdc54c8a2f2
849389amantadine HCl 100 MG Oral CapsulePSN3dd7f2a6-5a91-81a2-e063-6294a90a33db1
849389amantadine HCl 100 MG Oral CapsulePSNa3810649-1301-4332-85df-722b36867b1b1
849389amantadine hydrochloride 100 MG Oral CapsuleSCD3dd7f2a6-5a91-81a2-e063-6294a90a33db1
849389amantadine hydrochloride 100 MG Oral CapsuleSCDa3810649-1301-4332-85df-722b36867b1b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72888-033-00728880033001000 CAPSULE in 1 BOTTLE (72888-033-00) 1000 capsule2020-05-210000-00-00NoNoCurrent
72888-033-0172888003301100 CAPSULE in 1 BOTTLE (72888-033-01) 100 capsule2020-05-210000-00-00NoNoCurrent
72888-033-0572888003305500 CAPSULE in 1 BOTTLE (72888-033-05) 500 capsule2020-05-210000-00-00NoNoCurrent
72888-033-307288800333030 CAPSULE in 1 BOTTLE (72888-033-30) 30 capsule2020-05-210000-00-00NoNoCurrent