Amantadine Hydrochloride

Product NDC
50090-0020
11-digit product format
500900020
Labeler code
50090
Product ID
50090-0020_26781687-0a06-4c40-98bb-618bc0d584dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA071293
Marketing category
ANDA
Marketing start
1987-02-18
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0020-02023-01-30C16284748780-1f386c649-fc69-0266-e053-dadaa90a7c1aAmantadine Hydrochloride Capsules, USP Rx only
50090-0020-32023-01-30C16284748780-1f386c649-fc69-0266-e053-dadaa90a7c1aAmantadine Hydrochloride Capsules, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0020-0Amantadine Hydrochloride16 in 1 BOTTLECAPSULE168
50090-0020-3Amantadine Hydrochloride10 in 1 BOTTLECAPSULE108

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMANTADINE HYDROCHLORIDEACTIVE INGREDIENTM6Q1EO9TD0AMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
AMANTADINEACTIVE MOIETYBF4C9Z1J53AMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
ETHYLCELLULOSE (7 MPA.S)INACTIVE INGREDIENTH3UP11403CAMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LAMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0020AMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20190225_da693bb0-0cc8-485d-89a7-c8cf28d440f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSNda693bb0-0cc8-485d-89a7-c8cf28d440f38
849389amantadine hydrochloride 100 MG Oral CapsuleSCDda693bb0-0cc8-485d-89a7-c8cf28d440f38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0020-05009000200016 CAPSULE in 1 BOTTLE (50090-0020-0) 16 capsule2018-10-020000-00-00NoNoCurrent
50090-0020-35009000200310 CAPSULE in 1 BOTTLE (50090-0020-3) 10 capsule2014-11-28NoNoHistorical