FDA.reportPublic FDA data

memantine hydrochloride

Product NDC
68180-249
11-digit product format
681800249
Labeler code
68180
Product ID
68180-249_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
28 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 HYDROCHLORIDE28 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
68180-249-02memantine hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50017
68180-249-06memantine hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3017
68180-249-09memantine hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-249-02EA - Each68180-249079dc4f2-8a7d-4904-adf5-590493048dd112018-03-08
68180-249-06EA - Each68180-249a0b295af-6837-4161-b96c-c3b5dc123a9712018-03-08
68180-249-09EA - Each68180-249b554b0f0-0352-4f1e-947d-d25d2beee23512018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-249MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 3 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 CapsulePSNe2a371f6-8bfe-4049-b9ca-0ab3d726379e17
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
99660924 HR memantine hydrochloride 28 MG Extended Release Oral CapsuleSCDe2a371f6-8bfe-4049-b9ca-0ab3d726379e17
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
996609memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSYe2a371f6-8bfe-4049-b9ca-0ab3d726379e17
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-249-0268180024902500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68180-249-02) 2018-02-200000-00-00NoNoCurrent
68180-249-066818002490630 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68180-249-06) 2018-02-200000-00-00NoNoCurrent
68180-249-096818002490990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68180-249-09) 2018-02-200000-00-00NoNoCurrent
68180-249-136818002491310 BLISTER PACK in 1 CARTON (68180-249-13) > 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68180-249-11) 10 blister pack2018-02-200000-00-00NoNoCurrent