FDA.reportPublic FDA data

Memantine hydrochloride

Product NDC
33342-221
11-digit product format
333420221
Labeler code
33342
Product ID
33342-221_1c695653-b7dd-40af-b5eb-a6e3ecbab14d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA206310
Marketing category
ANDA
Marketing start
2025-08-28
Substance
MEMANTINE HYDROCHLORIDE
Active strength
21 mg/1
Pharmacologic classes
N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A206310-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-28
A206310-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-28
A206310-003MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-28
A206310-004MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206310-001AB
A206310-002AB
A206310-003AB
A206310-004AB

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
2026-08-18 06:07:402026-07A206310-001MEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A206310-002MEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A206310-003MEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A206310-004MEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206310-001MEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206310-002MEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206310-003MEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206310-004MEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206310-001MEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206310-002MEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206310-003MEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206310-004MEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-2831067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206310-001MEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206310-002MEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206310-003MEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206310-004MEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A206310-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206310-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206310-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206310-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206310-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206310-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206310-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206310-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206310-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206310-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206310-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206310-004AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206310-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206310-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206310-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206310-004AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Memantine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEMANTINE HYDROCHLORIDE21 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
62e32b0b-1eb2-424d-bfd2-d27ef27d35f3Available 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
33342-221-07Memantine hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302
33342-221-12Memantine hydrochloride10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE102
33342-221-12Memantine hydrochloride10 in 1 CARTONCAPSULE, EXTENDED RELEASE102

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine hydrochlorideMEMANTINE HYDROCHLORIDEMacleods Pharmaceuticals Limited62e32b0b-1eb2-424d-bfd2-d27ef27d35f32025-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206310
application number: ANDA206310
ndc (product): 33342-221

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996594memantine HCl 14 MG 24HR Extended Release Oral CapsulePSN62e32b0b-1eb2-424d-bfd2-d27ef27d35f32
996603memantine HCl 21 MG 24HR Extended Release Oral CapsulePSN62e32b0b-1eb2-424d-bfd2-d27ef27d35f32
996609memantine HCl 28 MG 24HR Extended Release Oral CapsulePSN62e32b0b-1eb2-424d-bfd2-d27ef27d35f32
996615memantine HCl 7 MG 24HR Extended Release Oral CapsulePSN62e32b0b-1eb2-424d-bfd2-d27ef27d35f32
99659424 HR memantine hydrochloride 14 MG Extended Release Oral CapsuleSCD62e32b0b-1eb2-424d-bfd2-d27ef27d35f32
99660324 HR memantine hydrochloride 21 MG Extended Release Oral CapsuleSCD62e32b0b-1eb2-424d-bfd2-d27ef27d35f32
99660924 HR memantine hydrochloride 28 MG Extended Release Oral CapsuleSCD62e32b0b-1eb2-424d-bfd2-d27ef27d35f32
99661524 HR memantine hydrochloride 7 MG Extended Release Oral CapsuleSCD62e32b0b-1eb2-424d-bfd2-d27ef27d35f32
996594memantine hydrochloride 14 MG 24 HR Extended Release Oral CapsuleSY62e32b0b-1eb2-424d-bfd2-d27ef27d35f32
996603memantine hydrochloride 21 MG 24 HR Extended Release Oral CapsuleSY62e32b0b-1eb2-424d-bfd2-d27ef27d35f32
996609memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSY62e32b0b-1eb2-424d-bfd2-d27ef27d35f32
996615memantine hydrochloride 7 MG 24 HR Extended Release Oral CapsuleSY62e32b0b-1eb2-424d-bfd2-d27ef27d35f32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-221-073334202210730 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-221-07) 2025-08-28NoNoCurrent
33342-221-123334202211210 BLISTER PACK in 1 CARTON (33342-221-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2025-08-28NoNoCurrent