FDA.reportPublic FDA data

memantine hydrochloride

Product NDC
0904-6734
11-digit product format
009046734
Labeler code
0904
Product ID
0904-6734_64e26acf-3799-4ad1-b91f-cf5766e5ada9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA206028
Marketing category
ANDA
Marketing start
2018-02-20
Substance
MEMANTINE HYDROCHLORIDE
Active strength
7 mg/1
Pharmacologic classes
N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
A206028-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28
A206028-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28
A206028-003MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28
A206028-004MEMANTINE 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
A206028-001AB
A206028-002AB
A206028-003AB
A206028-004AB

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 22:54:322026-06A206028-001MEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28a50c72e98297…
2026-08-01 22:54:322026-06A206028-002MEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28a50c72e98297…
2026-08-01 22:54:322026-06A206028-003MEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28a50c72e98297…
2026-08-01 22:54:322026-06A206028-004MEMANTINE 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 22:54:322026-06A206028-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A206028-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A206028-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A206028-004AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
memantine hydrochlorideMEMANTINE HYDROCHLORIDELupin Pharmaceuticals, Inc.24290655-47f3-4042-a977-a832c5161d2c2026-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206028
application number: ANDA206028
memantine hydrochlorideMEMANTINE HYDROCHLORIDEMajor Pharmaceuticalsf6ce7cca-d245-44f2-986c-2a8d85dbb5fb2026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206028
application number: ANDA206028
ndc (product): 0904-6734

Additional Listing Data#

Finished product
Yes
Brand name base
memantine hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEMANTINE HYDROCHLORIDE7 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JY0WD0UA60Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
996594Internal RxNorm lookup
996603Internal RxNorm lookup
996609Internal RxNorm lookup
996615Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f6ce7cca-d245-44f2-986c-2a8d85dbb5fbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
941773f8-a40e-0684-da08-ff9a143e6368Product name720231219
5b597f00-4538-4686-aa4e-3c60ed3788c8Product name220210511
1836e79a-a4d1-4087-2f2e-f878e8a1fef2Product name920151209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6734-61memantine hydrochloride1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE16
0904-6734-61memantine hydrochloride100 in 1 CARTONCAPSULE, EXTENDED RELEASE1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6734-61EA - Each0904-673442b5e416-f1c7-4254-bad7-7d76b14a44ec12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6734MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20250418_f6ce7cca-d245-44f2-986c-2a8d85dbb5fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996594memantine HCl 14 MG 24HR Extended Release Oral CapsulePSNf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996603memantine HCl 21 MG 24HR Extended Release Oral CapsulePSNf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996609memantine HCl 28 MG 24HR Extended Release Oral CapsulePSNf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996615memantine HCl 7 MG 24HR Extended Release Oral CapsulePSNf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
99659424 HR memantine hydrochloride 14 MG Extended Release Oral CapsuleSCDf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
99660324 HR memantine hydrochloride 21 MG Extended Release Oral CapsuleSCDf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
99660924 HR memantine hydrochloride 28 MG Extended Release Oral CapsuleSCDf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
99661524 HR memantine hydrochloride 7 MG Extended Release Oral CapsuleSCDf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996594memantine hydrochloride 14 MG 24 HR Extended Release Oral CapsuleSYf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996603memantine hydrochloride 21 MG 24 HR Extended Release Oral CapsuleSYf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996609memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSYf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996615memantine hydrochloride 7 MG 24 HR Extended Release Oral CapsuleSYf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6734-6100904673461100 BLISTER PACK in 1 CARTON (0904-6734-61) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK100 blister pack2018-02-200000-00-00NoNoCurrent