FDA.reportPublic FDA data

Memantine hydrochloride

Product NDC
33342-222
11-digit product format
333420222
Labeler code
33342
Product ID
33342-222_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
28 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 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
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
2026-08-01 22:54:322026-06A206310-001MEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-28a50c72e98297…
2026-08-01 22:54:322026-06A206310-002MEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-28a50c72e98297…
2026-08-01 22:54:322026-06A206310-003MEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-28a50c72e98297…
2026-08-01 22:54:322026-06A206310-004MEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2025-08-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206310-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A206310-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A206310-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A206310-004AB1a50c72e98297…

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 hydrochlorideMEMANTINE HYDROCHLORIDEMacleods Pharmaceuticals Limited62e32b0b-1eb2-424d-bfd2-d27ef27d35f32025-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206310
application number: ANDA206310
ndc (product): 33342-222

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEMANTINE HYDROCHLORIDE28 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
33342-222-07Memantine hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302
33342-222-12Memantine hydrochloride10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE102
33342-222-12Memantine hydrochloride10 in 1 CARTONCAPSULE, EXTENDED RELEASE102

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
33342-222-073334202220730 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-222-07) 2025-08-28NoNoCurrent
33342-222-123334202221210 BLISTER PACK in 1 CARTON (33342-222-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2025-08-28NoNoCurrent