FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
0378-1104
11-digit product format
003781104
Labeler code
0378
Product ID
0378-1104_4b207674-ac13-44ea-a422-834a9e86d7f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA079225
Marketing category
ANDA
Marketing start
2015-07-11
Marketing end
2019-10-31
Substance
MEMANTINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-1104DDiscontinued by firm2026-07-31
excluded packagepackage0378-11040378-1104-91DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079225-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORAL2015-01-30
A079225-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE10MGTABLET / ORAL2015-01-30

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A079225-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORAL2015-01-30a50c72e98297…
2026-08-01 22:54:322026-06A079225-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORAL2015-01-30a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1104-91EA - Each0378-110438c01c37-c166-4104-ae17-055c25642c8c12015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEMANTINE HYDROCHLORIDEACTIVE INGREDIENTJY0WD0UA60MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN INSTITUTIONAL INC.]2
MEMANTINE HYDROCHLORIDEACTIVE INGREDIENTJY0WD0UA60MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN PHARMACEUTICALS INC.]2
MEMANTINEACTIVE MOIETYW8O17SJF3TMEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN PHARMACEUTICALS INC.]2
MEMANTINEACTIVE MOIETYW8O17SJF3TMEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN PHARMACEUTICALS INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN INSTITUTIONAL INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN INSTITUTIONAL INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN PHARMACEUTICALS INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN PHARMACEUTICALS INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN PHARMACEUTICALS INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN PHARMACEUTICALS INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN INSTITUTIONAL INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN PHARMACEUTICALS INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN INSTITUTIONAL INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UMEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN INSTITUTIONAL INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UMEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN PHARMACEUTICALS INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN PHARMACEUTICALS INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN INSTITUTIONAL INC.]2