FDA.reportPublic FDA data

NDC 00527-1704 - Amantadine HCl

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
00527-1704
Manufacturer
Rebel Distributors Corp.
Effective date
2010-09-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amantadine HCl - Rebel Distributors Corp.Rebel Distributors Corp.2010-09-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMANTADINE HYDROCHLORIDEACTIVE INGREDIENTM6Q1EO9TD0AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
AMANTADINEACTIVE MOIETYBF4C9Z1J53AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
GELATININACTIVE INGREDIENT2G86QN327LAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
SORBITANINACTIVE INGREDIENT6O92ICV9RUAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
SORBITOLINACTIVE INGREDIENT506T60A25RAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
SOYBEAN OILINACTIVE INGREDIENT241ATL177AAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1

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 73 of 121 · 2,402 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
amantadineAMANTADINEAlembic Pharmaceuticals Inc.4157d9a7-a53f-4dde-b051-fe3e9a6749132025-06-04Warnings, Adverse reactionsExact identifier
rxcui: 849389
unii: M6Q1EO9TD0
amantadine hydrochlorideAMANTADINE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.609dc911-1e9d-4ebd-b64b-f44054e5582e2025-06-04Warnings, Adverse reactionsExact identifier
rxcui: 849389
unii: M6Q1EO9TD0
amantadine hydrochlorideAMANTADINE HYDROCHLORIDEZydus Lifesciences Limited579e6c23-6286-4b80-88de-c86c0e5cc2b22025-06-04Warnings, Adverse reactionsExact identifier
rxcui: 849389
unii: M6Q1EO9TD0
Age Defense for Eyes 5 in 1ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.48d5343a-1068-4c64-a275-c180026d69472025-06-03WarningsExact identifier
unii: 15FIX9V2JP
Bluevado SunfixZINC OXIDE, TITANIUM DIOXIDEMagic Blue, LLC31f1e961-3719-f70a-e063-6394a90a481e2025-05-31WarningsExact identifier
unii: 15FIX9V2JP
Code Red Eye Drops MicroGLYCERIN AND NAPHAZOLINE HYDROCHLORIDE4 Trees LLC2a15ea9a-ff67-446b-8b83-6517d25ff38a2025-05-29WarningsExact identifier
unii: PDC6A3C0OX
Dr. Mercola Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDENatural Health Partners, LLC47f6ab9e-fa73-496a-e054-00144ff8d46c2025-05-28WarningsExact identifier
unii: 15FIX9V2JP
Protect Daily Ritual Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35ce8307-387b-2b40-e063-6294a90a28bc2025-05-23Exact identifier
unii: 15FIX9V2JP
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35bea4f3-c19e-3e2e-e063-6394a90aeb692025-05-22Exact identifier
unii: 15FIX9V2JP
AmantadineAMANTADINEXttrium Laboratories, Inc25dd8a3c-6b11-2ea1-e063-6294a90a50cf2025-05-21Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Mineral Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC3595149d-0735-6bea-e063-6394a90a618a2025-05-20Exact identifier
unii: 15FIX9V2JP
Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC3595735e-c25f-eb48-e063-6294a90aac0f2025-05-20Exact identifier
unii: 15FIX9V2JP
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Biotrue Hydration BoostGLYCERINBausch & Lomb Incorporatede2621477-e6ee-4275-ba0a-939dca2550c42025-05-19WarningsExact identifier
unii: PDC6A3C0OX
ThroatSprayECHINACEA (ANGUSTIFOLIA), EUGENIA CARYOPHYLLATA, GLYCERINUM, MYRRHA, SALVIA OFFICINALIS, SPILANTHES OLERACEA, THYMUS SERPYLLUM, BAPTISIA TINCTORIA, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUMEnergique, Inc.3c4c3e7f-0ef9-4de0-b0bf-97fe7f6a527c2025-05-16WarningsExact identifier
unii: PDC6A3C0OX
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDEATLANTIC BIOLOGICALS CORP.6311b46b-23cc-40c1-93c2-f7c92606386f2025-05-12Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Bright Guard Sport SPFZINC SPFRENU LABORATORIES, LLCc9b48a9e-d69f-65a7-e053-2995a90a0baf2025-05-12WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6aa46-657b-2676-e063-6294a90abadd2025-05-09Exact identifier
unii: 15FIX9V2JP
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a5a99f-9e22-52ab-e063-6294a90a93232025-05-08Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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