FDA.reportPublic FDA data

Memantine hydrochloride

Product NDC
70771-1323
11-digit product format
707711323
Labeler code
70771
Product ID
70771-1323_900483ef-de89-464c-a324-8bfaa8f137a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA203293
Marketing category
ANDA
Marketing start
2018-04-08
Substance
MEMANTINE HYDROCHLORIDE
Active strength
21 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 HYDROCHLORIDE21 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
70771-1323-2Memantine hydrochloride10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE105
70771-1323-3Memantine hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305
70771-1323-4Memantine hydrochloride10 in 1 CARTONCAPSULE, EXTENDED RELEASE105
70771-1323-9Memantine hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1323MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 4 package rows20241204_ec825bef-2313-45c2-8858-b43197680155.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996594memantine HCl 14 MG 24HR Extended Release Oral CapsulePSNec825bef-2313-45c2-8858-b431976801555
996603memantine HCl 21 MG 24HR Extended Release Oral CapsulePSNec825bef-2313-45c2-8858-b431976801555
996609memantine HCl 28 MG 24HR Extended Release Oral CapsulePSNec825bef-2313-45c2-8858-b431976801555
996615memantine HCl 7 MG 24HR Extended Release Oral CapsulePSNec825bef-2313-45c2-8858-b431976801555
99659424 HR memantine hydrochloride 14 MG Extended Release Oral CapsuleSCDec825bef-2313-45c2-8858-b431976801555
99660324 HR memantine hydrochloride 21 MG Extended Release Oral CapsuleSCDec825bef-2313-45c2-8858-b431976801555
99660924 HR memantine hydrochloride 28 MG Extended Release Oral CapsuleSCDec825bef-2313-45c2-8858-b431976801555
99661524 HR memantine hydrochloride 7 MG Extended Release Oral CapsuleSCDec825bef-2313-45c2-8858-b431976801555
996594memantine hydrochloride 14 MG 24 HR Extended Release Oral CapsuleSYec825bef-2313-45c2-8858-b431976801555
996603memantine hydrochloride 21 MG 24 HR Extended Release Oral CapsuleSYec825bef-2313-45c2-8858-b431976801555
996609memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSYec825bef-2313-45c2-8858-b431976801555
996615memantine hydrochloride 7 MG 24 HR Extended Release Oral CapsuleSYec825bef-2313-45c2-8858-b431976801555

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1323-27077113230210 in 1 BLISTER PACKHistorical
70771-1323-37077113230330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1323-3) 2018-04-080000-00-00NoNoCurrent
70771-1323-47077113230410 BLISTER PACK in 1 CARTON (70771-1323-4) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70771-1323-2) 10 blister pack2018-04-080000-00-00NoNoCurrent
70771-1323-97077113230990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1323-9) 2018-04-080000-00-00NoNoCurrent