Amantadine HCl

Product NDC
53808-0933
11-digit product format
538080933
Labeler code
53808
Product ID
53808-0933_6ba4824d-44d7-44e8-84ab-4e87dfec5674
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMANTADINE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA078720
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
14e11aaf-885f-472f-a02a-c6a3f28df907Product name120180515
82f46845-b4c7-48da-a389-ba5721b956c9Product name120171103
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0933-12020-01-31C16284748780-19d75b9d0-bda0-f424-e053-dadaa90a57ceAmantadine Hydrochloride Capsules, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0933-1Amantadine HCl30 in 1 BLISTER PACKCAPSULE, LIQUID FILLED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMANTADINE HYDROCHLORIDEACTIVE INGREDIENTM6Q1EO9TD0AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
AMANTADINEACTIVE MOIETYBF4C9Z1J53AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GELATININACTIVE INGREDIENT2G86QN327LAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SORBITANINACTIVE INGREDIENT6O92ICV9RUAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SORBITOLINACTIVE INGREDIENT506T60A25RAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SOYBEAN OILINACTIVE INGREDIENT241ATL177AAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0933AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20141003_e3ea1dbc-47cc-462d-a360-a3944f80b14c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSNe3ea1dbc-47cc-462d-a360-a3944f80b14c1
849389amantadine hydrochloride 100 MG Oral CapsuleSCDe3ea1dbc-47cc-462d-a360-a3944f80b14c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0933-15380809330130 in 1 BLISTER PACKHistorical