FDA.reportPublic FDA data

Namzaric

Product NDC
0456-1229
11-digit product format
004561229
Labeler code
0456
Product ID
0456-1229_e692ad24-728a-4402-bd13-943969743e8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride and donepezil hydrochloride
Dosage form
KIT
Route
ORAL
Labeler
Allergan, Inc.
Application
NDA206439
Marketing category
NDA
Marketing start
2016-11-28
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
941773f8-a40e-0684-da08-ff9a143e6368Product name720231219
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7Product name120221214
5b597f00-4538-4686-aa4e-3c60ed3788c8Product name220210511
d7e50b51-94ef-29ef-8273-837d555048c1Product name920160811
1836e79a-a4d1-4087-2f2e-f878e8a1fef2Product name920151209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0456-1229-04Namzaric1 in 1 CARTONKIT123
0456-1229-29Namzaric1 in 1 BOXKIT123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0456-1229-29EA - Each0456-122993b3d884-20dc-4ec5-a72d-6f6b15cada2e12017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
donepezil hydrochlorideACTIVE INGREDIENT3O2T2PJ89DNAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5
memantine hydrochlorideACTIVE INGREDIENTJY0WD0UA60NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5
donepezilACTIVE MOIETY8SSC91326PNAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5
memantineACTIVE MOIETYW8O17SJF3TNAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UNAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5
ethylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BNAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDNAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTNAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5
gelatinINACTIVE INGREDIENT2G86QN327LNAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5
hypromellosesINACTIVE INGREDIENT3NXW29V3WONAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XNAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5
magnesium stearateINACTIVE INGREDIENT70097M6I30NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5
medium-chain triglyceridesINACTIVE INGREDIENTC9H2L21V7UNAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5
oleic acidINACTIVE INGREDIENT2UMI9U37CPNAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ANAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5
povidonesINACTIVE INGREDIENTFZ989GH94ENAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5
shellacINACTIVE INGREDIENT46N107B71ONAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5
starch, cornINACTIVE INGREDIENTO8232NY3SJNAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5
sucroseINACTIVE INGREDIENTC151H8M554NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5
talcINACTIVE INGREDIENT7SEV7J4R1UNAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPNAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0456-1229NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) KIT [ALLERGAN, INC.]20Legacy NDC, 2 package rows20241109_90fedc32-19e5-480c-afc6-f35a5cf4b9aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1858971{7 (24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 14 MG Extended Release Oral Capsule [Namzaric]) / 7 (24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 21 MG Extended Release Oral Capsule [Namzaric]) / 7 (24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG Extended Release Oral Capsule [Namzaric]) / 7 (24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 7 MG Extended Release Oral Capsule [Namzaric]) } Pack [Namzaric Titration Pack]BPCK90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
1858970{7 (24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 14 MG Extended Release Oral Capsule) / 7 (24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 21 MG Extended Release Oral Capsule) / 7 (24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG Extended Release Oral Capsule) / 7 (24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 7 MG Extended Release Oral Capsule) } PackGPCK90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
1599805donepezil HCl 10 MG / memantine HCl 14 MG 24HR Extended Release Oral CapsulePSN90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
1805420donepezil HCl 10 MG / memantine HCl 21 MG 24HR Extended Release Oral CapsulePSN90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
1599803donepezil HCl 10 MG / memantine HCl 28 MG 24HR Extended Release Oral CapsulePSN90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
1805425donepezil HCl 10 MG / memantine HCl 7 MG 24HR Extended Release Oral CapsulePSN90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
1858970memantine and donepezil hydrochlorides titration pack 7 MG/10 MG (7), 14 MG/10 MG (7), 21 MG/10 MG (7), 28 MG/10 MG (7) Oral Capsule 28 Day PackPSN90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
1602588Namzaric 14 MG / 10 MG 24HR Extended Release Oral CapsulePSN90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
1805422Namzaric 21 MG / 10 MG 24HR Extended Release Oral CapsulePSN90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
1602594Namzaric 28 MG / 10 MG 24HR Extended Release Oral CapsulePSN90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
1805427Namzaric 7 MG / 10 MG 24HR Extended Release Oral CapsulePSN90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
1858971Namzaric Titration PackPSN90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
160258824 HR donepezil hydrochloride 10 MG / memantine hydrochloride 14 MG Extended Release Oral Capsule [Namzaric]SBD90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
180542224 HR donepezil hydrochloride 10 MG / memantine hydrochloride 21 MG Extended Release Oral Capsule [Namzaric]SBD90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
160259424 HR donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG Extended Release Oral Capsule [Namzaric]SBD90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
180542724 HR donepezil hydrochloride 10 MG / memantine hydrochloride 7 MG Extended Release Oral Capsule [Namzaric]SBD90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
159980524 HR donepezil hydrochloride 10 MG / memantine hydrochloride 14 MG Extended Release Oral CapsuleSCD90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
180542024 HR donepezil hydrochloride 10 MG / memantine hydrochloride 21 MG Extended Release Oral CapsuleSCD90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
159980324 HR donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG Extended Release Oral CapsuleSCD90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
180542524 HR donepezil hydrochloride 10 MG / memantine hydrochloride 7 MG Extended Release Oral CapsuleSCD90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
1599805donepezil hydrochloride 10 MG / memantine hydrochloride 14 MG 24 HR Extended Release Oral CapsuleSY90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
1805420donepezil hydrochloride 10 MG / memantine hydrochloride 21 MG 24HR Extended Release Oral CapsuleSY90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
1599803donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSY90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
1805425donepezil hydrochloride 10 MG / memantine hydrochloride 7 MG 24HR Extended Release Oral CapsuleSY90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
1858970memantine and donepezil hydrochlorides titration packSY90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
1602588Namzaric (donepezil HCl 10 MG / memantine HCl 14 MG) 24 HR Extended Release Oral CapsuleSY90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
1805422Namzaric (donepezil HCl 10 MG / memantine HCl 21 MG) 24 HR Extended Release Oral CapsuleSY90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
1602594Namzaric (donepezil HCl 10 MG / memantine HCl 28 MG) 24 HR Extended Release Oral CapsuleSY90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
1805427Namzaric (donepezil HCl 10 MG / memantine HCl 7 MG) 24 HR Extended Release Oral CapsuleSY90fedc32-19e5-480c-afc6-f35a5cf4b9aa23
1858971Namzaric Titration PackSY90fedc32-19e5-480c-afc6-f35a5cf4b9aa23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0456-1229-04004561229041 in 1 CARTONHistorical
0456-1229-29004561229291 BOX in 1 BOX (0456-1229-29) > 1 CARTON in 1 BOX > 1 KIT in 1 CARTON * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION1 box2016-11-280000-00-00NoNoCurrent