FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
65162-783
11-digit product format
651620783
Labeler code
65162
Product ID
65162-783_fb7782a5-2357-4a21-86a6-0eeaa7cdcea5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA205825
Marketing category
ANDA
Marketing start
2017-12-22
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
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
A205825-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2016-10-12
A205825-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2016-10-12
A205825-003MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2016-10-12
A205825-004MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2016-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205825-001AB
A205825-002AB
A205825-003AB
A205825-004AB

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 22:54:322026-06A205825-001MEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2016-10-12a50c72e98297…
2026-08-01 22:54:322026-06A205825-002MEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2016-10-12a50c72e98297…
2026-08-01 22:54:322026-06A205825-003MEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2016-10-12a50c72e98297…
2026-08-01 22:54:322026-06A205825-004MEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2016-10-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205825-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A205825-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A205825-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A205825-004AB1a50c72e98297…

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 HYDROCHLORIDEAmneal Pharmaceuticals LLCf2b7538d-8ca1-4ac7-a172-d268e2fa9a522025-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205825
application number: ANDA205825
ndc (product): 65162-783

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEMANTINE HYDROCHLORIDE14 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
f2b7538d-8ca1-4ac7-a172-d268e2fa9a52Available 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
65162-783-03Memantine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3019
65162-783-09Memantine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9019
65162-783-50Memantine Hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-783-03EA - Each65162-783e82bf9e4-1795-42e4-b7f1-c9277369b51512018-03-08
65162-783-09EA - Each65162-783e721f596-ad94-478c-89f6-db740c3f694212018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-783MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]19Current NDC, Legacy NDC, 3 package rows20250430_f2b7538d-8ca1-4ac7-a172-d268e2fa9a52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996594memantine HCl 14 MG 24HR Extended Release Oral CapsulePSNf2b7538d-8ca1-4ac7-a172-d268e2fa9a5219
996603memantine HCl 21 MG 24HR Extended Release Oral CapsulePSNf2b7538d-8ca1-4ac7-a172-d268e2fa9a5219
996609memantine HCl 28 MG 24HR Extended Release Oral CapsulePSNf2b7538d-8ca1-4ac7-a172-d268e2fa9a5219
996615memantine HCl 7 MG 24HR Extended Release Oral CapsulePSNf2b7538d-8ca1-4ac7-a172-d268e2fa9a5219
99659424 HR memantine hydrochloride 14 MG Extended Release Oral CapsuleSCDf2b7538d-8ca1-4ac7-a172-d268e2fa9a5219
99660324 HR memantine hydrochloride 21 MG Extended Release Oral CapsuleSCDf2b7538d-8ca1-4ac7-a172-d268e2fa9a5219
99660924 HR memantine hydrochloride 28 MG Extended Release Oral CapsuleSCDf2b7538d-8ca1-4ac7-a172-d268e2fa9a5219
99661524 HR memantine hydrochloride 7 MG Extended Release Oral CapsuleSCDf2b7538d-8ca1-4ac7-a172-d268e2fa9a5219
996594memantine hydrochloride 14 MG 24 HR Extended Release Oral CapsuleSYf2b7538d-8ca1-4ac7-a172-d268e2fa9a5219
996603memantine hydrochloride 21 MG 24 HR Extended Release Oral CapsuleSYf2b7538d-8ca1-4ac7-a172-d268e2fa9a5219
996609memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSYf2b7538d-8ca1-4ac7-a172-d268e2fa9a5219
996615memantine hydrochloride 7 MG 24 HR Extended Release Oral CapsuleSYf2b7538d-8ca1-4ac7-a172-d268e2fa9a5219

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-783-036516207830330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-783-03) 2017-12-220000-00-00NoNoCurrent
65162-783-096516207830990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-783-09) 2017-12-220000-00-00NoNoCurrent
65162-783-5065162078350500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-783-50) 2017-12-220000-00-00NoNoCurrent