Amantadine Hydrochloride

Product NDC
68151-2991
11-digit product format
681512991
Labeler code
68151
Product ID
68151-2991_7b27b7ac-4a47-40f2-b0ea-6885590b97bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA071293
Marketing category
ANDA
Marketing start
1987-02-18
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
E
Listing certified through
2018-12-31
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
14e11aaf-885f-472f-a02a-c6a3f28df907Product name120180515
82f46845-b4c7-48da-a389-ba5721b956c9Product name120171103

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-2991-02020-01-31C16284748780-19d75b9d0-1fe4-f424-e053-dadaa90a57ceAmantadine Hydrochloride Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-2991-0Amantadine Hydrochloride1 in 1 PACKAGECAPSULE13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMANTADINE HYDROCHLORIDEACTIVE INGREDIENTM6Q1EO9TD0AMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
AMANTADINEACTIVE MOIETYBF4C9Z1J53AMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
ETHYLCELLULOSE (7 MPA.S)INACTIVE INGREDIENTH3UP11403CAMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LAMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-2991AMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160805_076740b2-9a76-45e9-9d56-87e9f3b96e97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSN076740b2-9a76-45e9-9d56-87e9f3b96e973
849389amantadine hydrochloride 100 MG Oral CapsuleSCD076740b2-9a76-45e9-9d56-87e9f3b96e973

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-2991-0681512991001 in 1 PACKAGEHistorical