FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
16571-853
11-digit product format
165710853
Labeler code
16571
Product ID
16571-853_4ece2bda-d26f-494f-93df-bc53c494caf9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA206032
Marketing category
ANDA
Marketing start
2025-06-01
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

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
16571-853-03Memantine Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE303
16571-853-09Memantine Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-853-03EA - Each16571-8535da7a748-8ddd-4e78-bb00-5e9bbef6492a12025-09-12
16571-853-09EA - Each16571-8531bdc116e-32d3-4cb6-acfb-4ac0ee7ee89212025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-853MEMANTINE HYDROCHLORIDE (MEMANTINE) CAPSULE, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.]2Current NDC, 2 package rows20250424_a282fbed-8304-458e-a0e9-5eaccc95339b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996594memantine HCl 14 MG 24HR Extended Release Oral CapsulePSNa282fbed-8304-458e-a0e9-5eaccc95339b3
996603memantine HCl 21 MG 24HR Extended Release Oral CapsulePSNa282fbed-8304-458e-a0e9-5eaccc95339b3
996609memantine HCl 28 MG 24HR Extended Release Oral CapsulePSNa282fbed-8304-458e-a0e9-5eaccc95339b3
996615memantine HCl 7 MG 24HR Extended Release Oral CapsulePSNa282fbed-8304-458e-a0e9-5eaccc95339b3
99659424 HR memantine hydrochloride 14 MG Extended Release Oral CapsuleSCDa282fbed-8304-458e-a0e9-5eaccc95339b3
99660324 HR memantine hydrochloride 21 MG Extended Release Oral CapsuleSCDa282fbed-8304-458e-a0e9-5eaccc95339b3
99660924 HR memantine hydrochloride 28 MG Extended Release Oral CapsuleSCDa282fbed-8304-458e-a0e9-5eaccc95339b3
99661524 HR memantine hydrochloride 7 MG Extended Release Oral CapsuleSCDa282fbed-8304-458e-a0e9-5eaccc95339b3
996594memantine hydrochloride 14 MG 24 HR Extended Release Oral CapsuleSYa282fbed-8304-458e-a0e9-5eaccc95339b3
996603memantine hydrochloride 21 MG 24 HR Extended Release Oral CapsuleSYa282fbed-8304-458e-a0e9-5eaccc95339b3
996609memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSYa282fbed-8304-458e-a0e9-5eaccc95339b3
996615memantine hydrochloride 7 MG 24 HR Extended Release Oral CapsuleSYa282fbed-8304-458e-a0e9-5eaccc95339b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
16571-853-031657108530330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16571-853-03) 2025-06-01NoNoCurrent
16571-853-091657108530990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16571-853-09) 2025-06-01NoNoCurrent