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 65 of 121 · 2,402 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUN BUFF SPF 30 MINERAL SUNSCREENZINC OXIDE/TITANIUM DIOXIDESPF Ventures, LLC3f874062-ebab-8993-e063-6294a90abfc52025-09-24WarningsExact identifier
unii: 15FIX9V2JP
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF CREAMNeilmed Pharmaceuticals Inc.374dc1c0-4243-b272-e063-6394a90a5a6b2025-09-24WarningsExact identifier
unii: PDC6A3C0OX
ERBORIAN CC RED CORRECTERBORIAN CC RED CORRECT SPF 25- OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE CREAMKolmask Co., Ld.09ca2d4b-e0c2-9961-e063-6394a90aa82e2025-09-18Exact identifier
unii: 15FIX9V2JP
ELROEL Pang Pang Sun Cushion PlusZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.5ffaad65-f0b2-416a-b0a3-b92e880641e42025-09-18WarningsExact identifier
unii: 15FIX9V2JP
CVS SPF 50 Face SunscreenTITANIUM DIOXIDE, ZINC OXIDECVS26a69a47-947a-a478-e063-6394a90aa4682025-09-16WarningsExact identifier
unii: 15FIX9V2JP
PerikabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCc2eb5522-8572-45f4-869d-42f9fd251bb62025-09-15Warnings, Adverse reactionsExact identifier
unii: 241ATL177A
REFRESH OPTIVE DropsCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.80275190-d717-40ea-905b-5c8fbe986eac2025-09-15WarningsExact identifier
unii: PDC6A3C0OX
Refresh Relieva PF XtraCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.b51b8a75-8faa-430f-8f7e-ee58d3d13f2e2025-09-15WarningsExact identifier
unii: PDC6A3C0OX
Refresh RelievaCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.6b984fa2-4187-45ef-b7d3-15e720abc6672025-09-15WarningsExact identifier
unii: PDC6A3C0OX
Oasis Tears PF Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.640f95f4-c2e8-48ad-ad40-f76bbaddb0dc2025-09-12WarningsExact identifier
unii: PDC6A3C0OX
KabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCafeb4837-a759-4484-a76e-e04611c459e72025-09-11Warnings, Adverse reactionsExact identifier
unii: 241ATL177A
sunscreenTITANIUM DIOXIDE(NANO)Mingyu (guangdong) Cosmetics Technology Co., Ltd3e6fe9f3-486b-bba7-e063-6294a90adf372025-09-10WarningsExact identifier
unii: 15FIX9V2JP
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEMarlex Pharmaceuticals Inc25af52ee-9b29-4c07-a383-62d4537b63e02025-09-10Warnings, Adverse reactionsExact identifier
rxcui: 849389
unii: M6Q1EO9TD0
Oasis TEARS PF PLUS Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.5d080191-423d-4c0a-b5ae-2ccf5c4a67cb2025-09-08WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINRising Pharma Holdings, Inc.db539b39-9504-44d2-9bd5-ba6ffb4410242025-09-08WarningsExact identifier
unii: PDC6A3C0OX
Glycerin ChildrenGLYCERINRising Pharma Holdings, Inc.80a5a944-2882-4f8d-a955-ef827cead5f02025-09-08WarningsExact identifier
unii: PDC6A3C0OX
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3dbb07e2-971c-284d-e063-6294a90a437f2025-09-06WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6ENSULIZOLE,HOMOSALATE ,OCTINOXATE ,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3e069cb2-c4c5-abf5-e063-6394a90a56b02025-09-06WarningsExact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC08b52f29-c1a0-c673-e063-6294a90a9a7a2025-09-05WarningsExact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC08b8003f-40be-3380-e063-6294a90a4f6b2025-09-05WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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