memantine hydrochloride

Product NDC
68180-246
11-digit product format
681800246
Labeler code
68180
Product ID
68180-246_2eba035e-38ce-479d-8dc8-0bfdd2bffbcf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA206028
Marketing category
ANDA
Marketing start
2018-02-20
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
68180-246-06memantine hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-246-06EA - Each68180-246bc79c454-981c-4775-916a-332a599eb22512018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-246MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 1 package rows20240120_24290655-47f3-4042-a977-a832c5161d2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996594memantine HCl 14 MG 24HR Extended Release Oral CapsulePSN24290655-47f3-4042-a977-a832c5161d2c17
996603memantine HCl 21 MG 24HR Extended Release Oral CapsulePSN24290655-47f3-4042-a977-a832c5161d2c17
996609memantine HCl 28 MG 24HR Extended Release Oral CapsulePSN24290655-47f3-4042-a977-a832c5161d2c17
996615memantine HCl 7 MG 24HR Extended Release Oral CapsulePSN24290655-47f3-4042-a977-a832c5161d2c17
99659424 HR memantine hydrochloride 14 MG Extended Release Oral CapsuleSCD24290655-47f3-4042-a977-a832c5161d2c17
99660324 HR memantine hydrochloride 21 MG Extended Release Oral CapsuleSCD24290655-47f3-4042-a977-a832c5161d2c17
99660924 HR memantine hydrochloride 28 MG Extended Release Oral CapsuleSCD24290655-47f3-4042-a977-a832c5161d2c17
99661524 HR memantine hydrochloride 7 MG Extended Release Oral CapsuleSCD24290655-47f3-4042-a977-a832c5161d2c17
996594memantine hydrochloride 14 MG 24 HR Extended Release Oral CapsuleSY24290655-47f3-4042-a977-a832c5161d2c17
996603memantine hydrochloride 21 MG 24 HR Extended Release Oral CapsuleSY24290655-47f3-4042-a977-a832c5161d2c17
996609memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSY24290655-47f3-4042-a977-a832c5161d2c17
996615memantine hydrochloride 7 MG 24 HR Extended Release Oral CapsuleSY24290655-47f3-4042-a977-a832c5161d2c17
996594memantine HCl 14 MG 24HR Extended Release Oral CapsulePSNf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996603memantine HCl 21 MG 24HR Extended Release Oral CapsulePSNf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996609memantine HCl 28 MG 24HR Extended Release Oral CapsulePSNf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996615memantine HCl 7 MG 24HR Extended Release Oral CapsulePSNf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
99659424 HR memantine hydrochloride 14 MG Extended Release Oral CapsuleSCDf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
99660324 HR memantine hydrochloride 21 MG Extended Release Oral CapsuleSCDf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
99660924 HR memantine hydrochloride 28 MG Extended Release Oral CapsuleSCDf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
99661524 HR memantine hydrochloride 7 MG Extended Release Oral CapsuleSCDf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996594memantine hydrochloride 14 MG 24 HR Extended Release Oral CapsuleSYf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996603memantine hydrochloride 21 MG 24 HR Extended Release Oral CapsuleSYf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996609memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSYf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996615memantine hydrochloride 7 MG 24 HR Extended Release Oral CapsuleSYf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-246-0268180024602500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68180-246-02) 2018-02-200000-00-00NoNoCurrent
68180-246-066818002460630 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68180-246-06) 2018-02-200000-00-00NoNoCurrent
68180-246-096818002460990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68180-246-09) 2018-02-200000-00-00NoNoCurrent