FDA.reportPublic FDA data

MEMANTINE HYDROCHLORIDE

Product NDC
59651-408
11-digit product format
596510408
Labeler code
59651
Product ID
59651-408_7a208302-90f3-45d0-94fc-9fb38591c543
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MEMANTINE HYDROCHLORIDE
Dosage form
KIT
Labeler
Aurobindo Pharma Limited
Application
ANDA214651
Marketing category
ANDA
Marketing start
2021-08-09
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

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
59651-408-28MEMANTINE HYDROCHLORIDE1 in 1 BLISTER PACKKIT12
59651-408-28MEMANTINE HYDROCHLORIDE1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-408MEMANTINE 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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-408-28596510408281 BLISTER PACK in 1 CARTON (59651-408-28) / 1 KIT in 1 BLISTER PACK1 blister pack2021-08-090000-00-00NoNoCurrent