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 19 of 39 · 768 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEUpsher-Smith Laboratories, LLC5232b933-1df9-43b4-8ac2-61bfa4855e682025-07-09Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Schuessler Tissue Salts Silica 6X Cleanser and Conditioner 12SILICEAMartin & Pleasance Pty Ltd39620db9-5099-47f0-93ad-c00e6625c4622025-07-07WarningsExact identifier
unii: ETJ7Z6XBU4
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDEBAJAJ MEDICAL, LLC38fccce5-1f1e-9350-e063-6394a90a045a2025-07-02Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Arnica Calendula WoundARNICA CALENDULA WOUNDUriel Pharmacy, Inc38cfd292-4dbd-2caf-e063-6394a90a05272025-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
BacAPIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, MATRICARIA CHAMOMILLA FLOWERING TOP OIL, LACHESIS MUTA VENOM, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS WHOLE, TOXICODENDRON PUBESCENS LEAF, AND SILICON DIOXIDEZorex7ae38e0c-8e74-4fd5-8605-45e424a84d012025-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
Bambusa AurumBAMBUSA AURUMUriel Pharmacy Inc.43f3dd30-701f-4fa4-9743-d10051c6e6d42025-06-27WarningsExact identifier
unii: ETJ7Z6XBU4
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEBryant Ranch Prepacke3eb34af-6e25-4a3d-a7d2-e9a789e335cc2025-06-26Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Amantadine HClAMANTADINE HYDROCHLORIDEAvPAK461e6444-189e-62ed-6c61-1c36a04459c62025-06-24Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Amantadine HClAMANTADINE HYDROCHLORIDEAvKAREbfd129ae-8b0a-f118-b7d0-45d106290b632025-06-24Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Amantadine HClAMANTADINE HYDROCHLORIDEBionpharma Inc.d6ca4d20-72c5-496c-9ac7-1f5cb407a7422025-06-09Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
amantadine hydrochlorideAMANTADINE HYDROCHLORIDEEPIC PHARMA LLC0f70c79a-92a4-4a38-bbdd-900adc4c2e932025-06-06Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
HAIR STIMPEDICULUS CAPITIS, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAX, CALCAREA CARBONICA, CINCHONA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HYDROFLUORICUM ACIDUM, MERCURIUS SOLUBILIS, MEZEREUM, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, THUJA OCCIDENTALIS, VINCA MINORThe Wellness Center for Research and Education, Inc.8ecc05ff-ed5a-4157-9100-1c7912686f072025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
SLIMLYCOPODIUM CLAVATUM, ABIES CANADENSIS, AMMONIUM BROMATUM, AMMONIUM MURIATICUM, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), AMMONIUM CARBONICUM, FUCUS VESICULOSUS, CAPSICUM ANNUUM, ARGENTUM NITRICUM, KALI BICHROMICUM, SILICEA, GLANDULA SUPRARENALIS BOVINE, CALCAREA ARSENICICA, FERRUM METALLICUM, ANTIMONIUM CRUDUM, CALCAREA CARBONICA, GRAPHITES, KALI CARBONICUM, ANACARDIUM ORIENTALE, IODIUM, THYROIDINUM (SUIS), LEPTINThe Wellness Center for Research and Education5067953f-351e-4bb0-b165-8dc62077cdea2025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
BioTox Dental Foci RepairARNICA MONTANA, HYPERICUM PERFORATUM, PLANTAGO MAJOR, ACONITUM NAPELLUS, MERCURIUS SOLUBILIS, HEKLA LAVA, ARGENTUM NITRICUM, BELLADONNA, HEPAR SULPHURIS CALCAREUM, SILICEAThe Wellness Center For Research and Education767f8dd2-759f-4662-9b5c-b8832309363d2025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1b9498b7-125e-4314-baca-b62af6e5511c2025-06-06Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Silicea 6XSILICEA 6XTrue Botanica, LLC2cee8f0b-6d28-75e4-e063-6294a90a2e152025-06-05WarningsExact identifier
unii: ETJ7Z6XBU4
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDERising Pharma Holdings, Inc.6fd54e00-a714-4442-af95-2515ab3b2ac32025-06-04Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
amantadineAMANTADINEAlembic Pharmaceuticals Inc.4157d9a7-a53f-4dde-b051-fe3e9a6749132025-06-04Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
amantadine hydrochlorideAMANTADINE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.609dc911-1e9d-4ebd-b64b-f44054e5582e2025-06-04Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
amantadine hydrochlorideAMANTADINE HYDROCHLORIDEZydus Lifesciences Limited579e6c23-6286-4b80-88de-c86c0e5cc2b22025-06-04Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0

Reported adverse events (FAERS/openFDA)#

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