FDA.reportPublic FDA data

NDC 0832-0111-89 - Amantadine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0832-0111
Requested NDC
0832-0111-89
Package NDCs from labels
0832-0111-00, 0832-0111-50, 0832-0111-89, 0832-0111-03
Manufacturer
Upsher-Smith Laboratories, LLC | BORA Pharmaceuticals, Inc.
Effective date
2025-12-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amantadine Hydrochloride Tablets, USPUpsher-Smith Laboratories, LLC | BORA Pharmaceuticals, Inc.2025-12-11HUMAN PRESCRIPTION DRUG LABEL
Amantadine Hydrochloride Tablets, USPREMEDYREPACK INC.2024-01-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0832-0111-00Amantadine Hydrochloride100 in 1 BOTTLETABLET10011
0832-0111-03Amantadine Hydrochloride100 in 1 CARTONTABLET10011
0832-0111-50Amantadine Hydrochloride500 in 1 BOTTLETABLET50011
0832-0111-89Amantadine Hydrochloride1 in 1 BLISTER PACKTABLET111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-0111AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, LLC]8Current NDC, Legacy NDC, 4 package rows20230519_63d9d4aa-5f92-45b0-98d0-d6ec38b727cb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-0111-00EA - Each0832-0111ab567895-32cf-4caa-8bf0-d7e2d215a31112012-07-24
0832-0111-03EA - Each0832-0111b5e124ee-ca83-46f4-9318-ebe37de6533512017-08-11
0832-0111-50EA - Each0832-011110caabf1-f551-4977-bea9-b997beca8dab12012-07-24
0832-0111-89EA - Each0832-0111812c6bd3-9c38-4702-9416-3fc98c72c98512017-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
amantadine hydrochlorideACTIVE INGREDIENTM6Q1EO9TD0AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC]3
amantadineACTIVE MOIETYBF4C9Z1J53AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EAMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC]3
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TAMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC]3

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 38 of 38 · 743 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tox-ChordALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUMEnergetix Corp6b0d1628-b20d-426e-9c84-5cceadca3f452016-11-11WarningsExact identifier
unii: LMI26O6933
unii: ETJ7Z6XBU4
ThyrotoxCHONDRUS CRISPUS, FUCUS VESICULOSUS, THYROIDINUM, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, IODIUM, KALI CARBONICUM, PHOSPHORUS, PULSATILLA (VULGARIS), SILICEABioActive Nutritional, Inc.e229a260-13f3-4136-b325-9a8954f8a3272016-08-10WarningsExact identifier
unii: ETJ7Z6XBU4
TeethingARNICA MONTANA, TRIFOLIUM PRATENSE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CHAMOMILLA, KREOSOTUM, SILICEABioActive Nutritional, Inc.f39c9feb-f567-43a2-a026-2a581aeeed9d2016-07-27WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.