FDA.reportPublic FDA data

Amantadine Hydrochloride

Product NDC
0832-1015
11-digit product format
008321015
Labeler code
0832
Product ID
0832-1015_398493aa-8a67-10e2-e063-6394a90aef8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amantadine hydrochloride
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA070589
Marketing category
ANDA
Marketing start
2011-09-15
Marketing end
2026-12-31
Substance
AMANTADINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amantadine Hydrochloride

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0832-1015-00Amantadine Hydrochloride100 in 1 BOTTLECAPSULE, GELATIN COATED10019
0832-1015-50Amantadine Hydrochloride500 in 1 BOTTLECAPSULE, GELATIN COATED50019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-1015-00EA - Each0832-1015b4846ddb-7bc6-4d8c-8cd7-654fd0a2d43812012-07-24
0832-1015-50EA - Each0832-1015d5ded1c4-92c9-4c9b-a994-6642449235e212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
amantadine hydrochlorideACTIVE INGREDIENTM6Q1EO9TD0AMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC]12
amantadineACTIVE MOIETYBF4C9Z1J53AMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC]12
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC]12
GELATININACTIVE INGREDIENT2G86QN327LAMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC]12
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC]12
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAAMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC]12
HYDROGENATED SOYBEAN OILINACTIVE INGREDIENTA2M91M918CAMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC]12
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62AMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC]12
SOYBEAN OILINACTIVE INGREDIENT241ATL177AAMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC]12
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FAMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-1015AMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, LLC]18Current NDC, Legacy NDC, 2 package rows20230524_5232b933-1df9-43b4-8ac2-61bfa4855e68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSN5232b933-1df9-43b4-8ac2-61bfa4855e6819
849389amantadine hydrochloride 100 MG Oral CapsuleSCD5232b933-1df9-43b4-8ac2-61bfa4855e6819

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0832-1015-0000832101500100 CAPSULE, GELATIN COATED in 1 BOTTLE (0832-1015-00) 2011-09-152026-12-31NoNoCurrent
0832-1015-5000832101550500 CAPSULE, GELATIN COATED in 1 BOTTLE (0832-1015-50) 2011-09-152026-12-31NoNoCurrent