FDA.reportPublic FDA data

NDC 65862-652-10 - Memantine 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
65862-652
Requested NDC
65862-652-10
Package NDCs from labels
65862-652-60, 65862-652-99, 65862-652-10, 65862-652-03, 65862-652-78
Manufacturer
Aurobindo Pharma Limited
Effective date
2022-11-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Memantine Hydrochloride - Aurobindo Pharma LimitedAurobindo Pharma Limited2022-11-08Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-652-03Memantine Hydrochloride3 in 1 CARTONTABLET, FILM COATED39
65862-652-10Memantine Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED109
65862-652-60Memantine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED609
65862-652-78Memantine Hydrochloride10 in 1 CARTONTABLET, FILM COATED109
65862-652-99Memantine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-652MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]9Current NDC, Legacy NDC, 5 package rows20221109_ceb733fa-4526-4b76-ab6a-bd4c5638afff.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-652-60EA - Each65862-65261bc3c8a-cea7-4aa9-8b89-a208c39e1a4512015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEMANTINE HYDROCHLORIDEACTIVE INGREDIENTJY0WD0UA60MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
MEMANTINEACTIVE MOIETYW8O17SJF3TMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]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 57 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Matte Shield SPFTITANIUM DIOXIDE, ZINC OXIDEACNE SOLUTIONS NYC INC3bb582ec-71e7-4ad8-e063-6394a90a94d42025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral Based Sunscreen Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3245561d-a90c-7bf0-e063-6394a90ab3b62025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Based Sunscreen Stick TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3245c1f7-2c1b-b6ad-e063-6394a90aaee62025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Based Foam Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION32465271-abb9-d03f-e063-6294a90a990e2025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Based Foam Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION32486bfb-0cc8-0283-e063-6394a90a99672025-12-08Exact identifier
unii: 15FIX9V2JP
Healthy Mineral Sunscreen No Shine - No TintTITANIUM DIOXIDE, ZINC OXIDEZen Dermatology, Inc.31572a16-5f60-565f-e063-6394a90ab8c92025-12-08WarningsExact identifier
unii: 15FIX9V2JP
AcneFix Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEACNEFIX INC.315894b7-ac1b-0982-e063-6294a90ab8792025-12-08Exact identifier
unii: 15FIX9V2JP
Shunly Natural Cover SPF50TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Carea64e373b-b3f6-4024-b5f5-253783485cd62025-12-08WarningsExact identifier
unii: 15FIX9V2JP
AcneFix Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEACNEFIX INC.31583c7e-365a-d899-e063-6394a90aa63f2025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Fusion TintedTITANIUM DIOXIDE, ZINC OXIDEFOREFRONT DERMATOLOGY, S.C.334ec844-5560-50f7-e063-6394a90a01be2025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Fusion TintedTITANIUM DIOXIDE, ZINC OXIDEFOREFRONT DERMATOLOGY, S.C.334f90d6-68e5-db37-e063-6294a90a5fb12025-12-08Exact identifier
unii: 15FIX9V2JP
Silk ScreenTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c44baf4-9555-faad-e063-6294a90ab24f2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Glow StickTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c54b857-c017-a953-e063-6394a90a38df2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Lip ShieldTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c545e55-3f55-842b-e063-6394a90ae48e2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Bare Barrier SportTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c580794-eda3-de57-e063-6294a90a03032025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Flawless Brightening SunscreenTITANIUM DIOXIDE, ZINC OXIDEFlawless Skin Care LLC312e9ca0-a388-a546-e063-6294a90a15d62025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral SPF 40, protectTITANIUM DIOXIDE, ZINC OXIDEAcne Specialists LLC2f8859cf-8277-6ea9-e063-6294a90a1a752025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral SPF 40, TintedTITANIUM DIOXIDE, ZINC OXIDEAcne Specialists LLC2fb19ed7-8cee-ce80-e063-6394a90ad3dc2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral SPF 40, TintedTITANIUM DIOXIDE, ZINC OXIDEAcne Specialists LLC2fb14c4f-a435-aa6e-e063-6394a90a7d8d2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen SPF 40 Non-TintedTITANIUM DIOXIDE, ZINC OXIDESkin Restoration Aesthetics2fc4f701-eea2-7913-e063-6294a90a86932025-12-08WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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