FDA.reportPublic FDA data

memantine hydrochloride and donepezil hydrochloride

Product NDC
69680-185
11-digit product format
696800185
Labeler code
69680
Product ID
69680-185_ffe5cf41-299a-49e5-a9b8-c9048c4861fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride and donepezil hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Vitruvias Therapeutics, Inc.
Application
ANDA216901
Marketing category
ANDA
Marketing start
2025-07-16
Substance
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Active strength
10; 28 mg/1; mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216901-001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE10MG;14MGCAPSULE, EXTENDED RELEASE / ORALAB2025-07-15
A216901-002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE10MG;28MGCAPSULE, EXTENDED RELEASE / ORALAB2025-07-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A216901-001AB
A216901-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216901-001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MGCAPSULE, EXTENDED RELEASE / ORALAB2025-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216901-002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;28MGCAPSULE, EXTENDED RELEASE / ORALAB2025-07-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216901-001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MGCAPSULE, EXTENDED RELEASE / ORALAB2025-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216901-002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;28MGCAPSULE, EXTENDED RELEASE / ORALAB2025-07-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A216901-001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MGCAPSULE, EXTENDED RELEASE / ORALAB2025-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216901-002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;28MGCAPSULE, EXTENDED RELEASE / ORALAB2025-07-156a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216901-001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MGCAPSULE, EXTENDED RELEASE / ORALAB2025-07-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216901-002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;28MGCAPSULE, EXTENDED RELEASE / ORALAB2025-07-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216901-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216901-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216901-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216901-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216901-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216901-002AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216901-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216901-002AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
memantine hydrochloride and donepezil hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEMANTINE HYDROCHLORIDE10 mg/1
DONEPEZIL HYDROCHLORIDE28 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JY0WD0UA60Internal UNII lookup
3O2T2PJ89DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1599803Internal RxNorm lookup
1599805Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c888a2b2-92c6-46ae-99ea-21de616208b6Available on FDA.report

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
69680-185-30memantine hydrochloride and donepezil hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69680-185-30EA - Each69680-1852de6f0d1-4772-491f-b39c-fd38c660311912025-08-11

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
memantine hydrochloride and donepezil hydrochlorideMEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDEVitruvias Therapeutics, Inc.c888a2b2-92c6-46ae-99ea-21de616208b62025-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216901
application number: ANDA216901
ndc (product): 69680-185

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1599805donepezil HCl 10 MG / memantine HCl 14 MG 24HR Extended Release Oral CapsulePSNc888a2b2-92c6-46ae-99ea-21de616208b63
1599803donepezil HCl 10 MG / memantine HCl 28 MG 24HR Extended Release Oral CapsulePSNc888a2b2-92c6-46ae-99ea-21de616208b63
159980524 HR donepezil hydrochloride 10 MG / memantine hydrochloride 14 MG Extended Release Oral CapsuleSCDc888a2b2-92c6-46ae-99ea-21de616208b63
159980324 HR donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG Extended Release Oral CapsuleSCDc888a2b2-92c6-46ae-99ea-21de616208b63
1599805donepezil hydrochloride 10 MG / memantine hydrochloride 14 MG 24 HR Extended Release Oral CapsuleSYc888a2b2-92c6-46ae-99ea-21de616208b63
1599803donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSYc888a2b2-92c6-46ae-99ea-21de616208b63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69680-185-306968001853030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-185-30) 2025-07-16NoNoCurrent