FDA.reportPublic FDA data

MEMANTINE HYDROCHLORIDE

Product NDC
59651-405
11-digit product format
596510405
Labeler code
59651
Product ID
59651-405_7a208302-90f3-45d0-94fc-9fb38591c543
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MEMANTINE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA214651
Marketing category
ANDA
Marketing start
2021-08-09
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

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 Identifiers#

Field, Values table
FieldValues
UniiJY0WD0UA60
Rxcui996594, 996603, 996609, 996615, 996624

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
59651-405-30MEMANTINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302
59651-405-90MEMANTINE HYDROCHLORIDE90 in 1 BOTTLECAPSULE, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-405-30EA - Each59651-40503c6e0bf-e28c-4322-b20b-5355f5265e7612021-11-09
59651-405-90EA - Each59651-4054641f3d2-fc31-4fe4-843b-6c7c07784ddf12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-405MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE MEMANTINE HYDROCHLORIDE KIT [AUROBINDO PHARMA LIMITED]2Current NDC, Legacy NDC, 2 package rows20221106_2b2dcd54-47e0-494b-85d2-c28c3adbe737.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996624{7 (24 HR memantine hydrochloride 14 MG Extended Release Oral Capsule) / 7 (24 HR memantine hydrochloride 21 MG Extended Release Oral Capsule) / 7 (24 HR memantine hydrochloride 28 MG Extended Release Oral Capsule) / 7 (24 HR memantine hydrochloride 7 MG Extended Release Oral Capsule) } PackGPCK2b2dcd54-47e0-494b-85d2-c28c3adbe7372
996594memantine HCl 14 MG 24HR Extended Release Oral CapsulePSN2b2dcd54-47e0-494b-85d2-c28c3adbe7372
996603memantine HCl 21 MG 24HR Extended Release Oral CapsulePSN2b2dcd54-47e0-494b-85d2-c28c3adbe7372
996609memantine HCl 28 MG 24HR Extended Release Oral CapsulePSN2b2dcd54-47e0-494b-85d2-c28c3adbe7372
996624memantine HCl 7 MG (7), 14 MG (7), 21 MG (7), 28 MG (7) 24HR Extended Release Oral Capsule 28 Count PackPSN2b2dcd54-47e0-494b-85d2-c28c3adbe7372
996615memantine HCl 7 MG 24HR Extended Release Oral CapsulePSN2b2dcd54-47e0-494b-85d2-c28c3adbe7372
99659424 HR memantine hydrochloride 14 MG Extended Release Oral CapsuleSCD2b2dcd54-47e0-494b-85d2-c28c3adbe7372
99660324 HR memantine hydrochloride 21 MG Extended Release Oral CapsuleSCD2b2dcd54-47e0-494b-85d2-c28c3adbe7372
99660924 HR memantine hydrochloride 28 MG Extended Release Oral CapsuleSCD2b2dcd54-47e0-494b-85d2-c28c3adbe7372
99661524 HR memantine hydrochloride 7 MG Extended Release Oral CapsuleSCD2b2dcd54-47e0-494b-85d2-c28c3adbe7372
996594memantine hydrochloride 14 MG 24 HR Extended Release Oral CapsuleSY2b2dcd54-47e0-494b-85d2-c28c3adbe7372
996603memantine hydrochloride 21 MG 24 HR Extended Release Oral CapsuleSY2b2dcd54-47e0-494b-85d2-c28c3adbe7372
996609memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSY2b2dcd54-47e0-494b-85d2-c28c3adbe7372
996615memantine hydrochloride 7 MG 24 HR Extended Release Oral CapsuleSY2b2dcd54-47e0-494b-85d2-c28c3adbe7372
996624memantine hydrochloride titration pack 28; 7MG/14MG/21MG/28MG Extended Release Oral CapsuleSY2b2dcd54-47e0-494b-85d2-c28c3adbe7372

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59651-405-305965104053030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-405-30) 2021-08-090000-00-00NoNoCurrent
59651-405-905965104059090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-405-90) 2021-08-090000-00-00NoNoCurrent