Amantadine Hydrochloride

Product NDC
33261-773
11-digit product format
332610773
Labeler code
33261
Product ID
33261-773_1a42734f-af17-498b-bc15-a3f7e0004fae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
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
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
14e11aaf-885f-472f-a02a-c6a3f28df907Product name120180515
82f46845-b4c7-48da-a389-ba5721b956c9Product name120171103

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-773-10Amantadine Hydrochloride10 in 1 BOTTLE, PLASTICCAPSULE101
33261-773-30Amantadine Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE301
33261-773-60Amantadine Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE601
33261-773-90Amantadine Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-773-10EA - Each33261-773db4abbaa-0247-45f6-8d9a-085fceff6af812015-10-02
33261-773-30EA - Each33261-77349757fcf-fe2a-4741-9cb4-325aae8bc7b212015-10-02
33261-773-60EA - Each33261-773ce183fc3-994e-4f16-abf3-ec54ccfeb77b12015-10-02
33261-773-90EA - Each33261-77302806a09-2813-4aac-9d43-bc830d51a0ca12015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-773AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20131204_0637f133-1f9d-48b3-b82f-a4e16f926cd6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSN0637f133-1f9d-48b3-b82f-a4e16f926cd61
849389amantadine hydrochloride 100 MG Oral CapsuleSCD0637f133-1f9d-48b3-b82f-a4e16f926cd61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-773-103326107731010 in 1 BOTTLE, PLASTICHistorical
33261-773-303326107733030 in 1 BOTTLE, PLASTICHistorical
33261-773-603326107736060 in 1 BOTTLE, PLASTICHistorical
33261-773-903326107739090 in 1 BOTTLE, PLASTICHistorical