FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
0378-5437
11-digit product format
003785437
Labeler code
0378
Product ID
0378-5437_642189b4-b4ad-424a-9c89-4dcbde5b2773
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA206032
Marketing category
ANDA
Marketing start
2018-02-21
Marketing end
0000-00-00
Substance
MEMANTINE HYDROCHLORIDE
Active strength
21 mg/1
Pharmacologic classes
NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-5437DDiscontinued by firm2026-08-03
excluded packagepackage0378-54370378-5437-93DDiscontinued 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206032-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28
A206032-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28
A206032-003MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28
A206032-004MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A206032-001AB
A206032-002AB
A206032-003AB
A206032-004AB

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 22:54:322026-06A206032-001MEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28a50c72e98297…
2026-08-01 22:54:322026-06A206032-002MEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28a50c72e98297…
2026-08-01 22:54:322026-06A206032-003MEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28a50c72e98297…
2026-08-01 22:54:322026-06A206032-004MEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206032-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A206032-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A206032-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A206032-004AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINERising Pharma Holdings, Inc.a282fbed-8304-458e-a0e9-5eaccc95339b2025-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206032
application number: ANDA206032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-5437-93EA - Each0378-54370d7a9f92-6ec5-4dfb-8d47-7be00efe480012018-03-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-5437-930037854379330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-5437-93) 2018-02-210000-00-00NoNoCurrent