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 3 of 39 · 768 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
AmantadineAMANTADINEAmerican Health Packaging5119801d-a5cb-4adf-96b2-08cc3a0ba5942026-06-23Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
amantadine hydrochlorideAMANTADINE HYDROCHLORIDEAvKARE547904f3-84a3-1ccb-e063-6294a90a6fb62026-06-17Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
H-Scars FormulaCALENDULA OFFICINALLIS, SILICEAHealing Natural Oils LLC8433ff00-d815-45e0-b0ec-1448668dd8f82026-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro543bc298-ec32-38e9-e063-6394a90aac152026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nail Fungus Control Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Natured02b88a6-1999-4dcd-91b5-fad88a664fcb2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nerve PainARABICA COFFEE BEAN, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Naturea9c3ba2e-9254-4ccd-9fe9-7a360fdf2bb72026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Scar ControlCALENDULA OFFICINALIS FLOWERING TOP, ALLYLTHIOUREA, AND SILICON DIOXIDEForces of Nature595c3423-6b52-48fc-8a95-00b53c1ecc7b2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICATotal Operations Management LLC DBA:Bestmade Natural Products Micro54243745-bd67-19c1-e063-6394a90a4b722026-06-13WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICABM Private Limited540d8fbe-3bdb-1b54-e063-6394a90a114d2026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCTotal Operations Management LLC DBA:Bestmade Natural Products Micro540e4ee3-596f-4cea-e063-6294a90a6a602026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4
Jacksons Cell Salts SKIN BALANCECALC SULPH, KALI SULPH, SILICEAZettl Health Inc.54012f03-4c34-42f5-e063-6394a90aacc52026-06-11WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCBM Private Limited53e763ee-9a44-a914-e063-6394a90aeb3c2026-06-10WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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