FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
70436-054
11-digit product format
704360054
Labeler code
70436
Product ID
70436-054_5003d132-8e5e-799f-e063-6394a90a5029
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA211100
Marketing category
ANDA
Marketing start
2021-11-15
Substance
MEMANTINE HYDROCHLORIDE
Active strength
7 mg/1
Pharmacologic classes
N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Memantine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEMANTINE HYDROCHLORIDE7 mg/1

Harmonized Identifiers#

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

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
70436-054-04Memantine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-054-04EA - Each70436-05441802440-98f2-480e-8098-326de14850b712021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-054MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SLATE RUN PHARMACEUTICALS, LLC]14Current NDC, Legacy NDC, 1 package rows20250416_a74050c4-5a37-4fa1-85d9-85831525cfeb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996594memantine HCl 14 MG 24HR Extended Release Oral CapsulePSNa74050c4-5a37-4fa1-85d9-85831525cfeb16
996603memantine HCl 21 MG 24HR Extended Release Oral CapsulePSNa74050c4-5a37-4fa1-85d9-85831525cfeb16
996609memantine HCl 28 MG 24HR Extended Release Oral CapsulePSNa74050c4-5a37-4fa1-85d9-85831525cfeb16
996615memantine HCl 7 MG 24HR Extended Release Oral CapsulePSNa74050c4-5a37-4fa1-85d9-85831525cfeb16
99659424 HR memantine hydrochloride 14 MG Extended Release Oral CapsuleSCDa74050c4-5a37-4fa1-85d9-85831525cfeb16
99660324 HR memantine hydrochloride 21 MG Extended Release Oral CapsuleSCDa74050c4-5a37-4fa1-85d9-85831525cfeb16
99660924 HR memantine hydrochloride 28 MG Extended Release Oral CapsuleSCDa74050c4-5a37-4fa1-85d9-85831525cfeb16
99661524 HR memantine hydrochloride 7 MG Extended Release Oral CapsuleSCDa74050c4-5a37-4fa1-85d9-85831525cfeb16
996594memantine hydrochloride 14 MG 24 HR Extended Release Oral CapsuleSYa74050c4-5a37-4fa1-85d9-85831525cfeb16
996603memantine hydrochloride 21 MG 24 HR Extended Release Oral CapsuleSYa74050c4-5a37-4fa1-85d9-85831525cfeb16
996609memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSYa74050c4-5a37-4fa1-85d9-85831525cfeb16
996615memantine hydrochloride 7 MG 24 HR Extended Release Oral CapsuleSYa74050c4-5a37-4fa1-85d9-85831525cfeb16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70436-054-047043600540430 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-054-04) 2021-11-150000-00-00NoNoCurrent