FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
63629-1983
Requested package NDC
63629-1983-1
11-digit product format
636291983
Labeler code
63629
Product ID
63629-1983_9278afce-29e9-493f-9bd0-21a50b6c7e17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205365
Marketing category
ANDA
Marketing start
2020-05-19
Marketing end
0000-00-00
Substance
MEMANTINE HYDROCHLORIDE
Active strength
14 mg/1
Pharmacologic classes
N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-198363629-1983-1DDiscontinued 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205365-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORAL2020-02-28
A205365-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORAL2020-02-28
A205365-003MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORAL2020-02-28
A205365-004MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORAL2020-02-28

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 22:54:322026-06A205365-001MEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORAL2020-02-28a50c72e98297…
2026-08-01 22:54:322026-06A205365-002MEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORAL2020-02-28a50c72e98297…
2026-08-01 22:54:322026-06A205365-003MEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORAL2020-02-28a50c72e98297…
2026-08-01 22:54:322026-06A205365-004MEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORAL2020-02-28a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1983-1EA - Each63629-1983852e4efc-f207-4196-82b1-e36c2199fc6812021-03-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1983-16362919830190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-1983-1) 2020-05-190000-00-00NoNoCurrent