FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
68788-7165
11-digit product format
687887165
Labeler code
68788
Product ID
68788-7165_00698ee1-6ba4-4581-90e8-3954a7ba1cb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA202840
Marketing category
ANDA
Marketing start
2018-06-05
Marketing end
0000-00-00
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
2022-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-7165DDiscontinued by firm2026-08-03
excluded packagepackage68788-716568788-7165-3DDiscontinued by firm2026-08-03
excluded packagepackage68788-716568788-7165-6DDiscontinued by firm2026-08-03
excluded packagepackage68788-716568788-7165-9DDiscontinued by firm2026-08-03

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
A202840-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13
A202840-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A202840-001AB
A202840-002AB

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 22:54:322026-06A202840-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13a50c72e98297…
2026-08-01 22:54:322026-06A202840-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202840-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A202840-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEA-S Medication Solutions66db6d61-cf1d-46ca-a645-19e9a20f46172023-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202840
application number: ANDA202840
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEMacleods Pharmaceuticals Limited989fa756-7d70-4ea7-bb5e-f4395e48589d2022-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202840
application number: ANDA202840

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7165-3EA - Each68788-7165910d29d2-c56f-4c9b-834e-0ed892f4cb4312018-08-13
68788-7165-6EA - Each68788-71650ef16a8a-28dc-4e2e-8d4b-5e093c03686412018-08-13
68788-7165-9EA - Each68788-71653f43b801-e496-42e9-987c-d0174608037812018-08-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7165-36878871650330 TABLET in 1 BOTTLE (68788-7165-3) 30 tablet2018-06-050000-00-00NoNoCurrent
68788-7165-66878871650660 TABLET in 1 BOTTLE (68788-7165-6) 60 tablet2018-06-050000-00-00NoNoCurrent
68788-7165-96878871650990 TABLET in 1 BOTTLE (68788-7165-9) 90 tablet2018-06-050000-00-00NoNoCurrent