Memantine and Donepezil Hydrochlorides Extended-release

Product NDC
73190-004
Requested package NDC
73190-004-30
11-digit product format
731900004
Labeler code
73190
Product ID
73190-004_2d821398-bb64-e4dc-e063-6294a90a6c51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine and Donepezil
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA208328
Marketing category
ANDA
Marketing start
2025-02-06
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208328-001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE10MG;14MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-27
A208328-002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE10MG;28MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-27
A208328-003MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE10MG;7MGCAPSULE, EXTENDED RELEASE / ORALAB2025-02-27
A208328-004MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE10MG;21MGCAPSULE, EXTENDED RELEASE / ORALAB2025-02-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A208328-001AB
A208328-002AB
A208328-003AB
A208328-004AB

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.

Product history page 1 of 3 · 92 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208328-001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208328-002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;28MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208328-003MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;7MGCAPSULE, EXTENDED RELEASE / ORALAB2025-02-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208328-004MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;21MGCAPSULE, EXTENDED RELEASE / ORALAB2025-02-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208328-001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208328-002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;28MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208328-003MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;7MGCAPSULE, EXTENDED RELEASE / ORALAB2025-02-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208328-004MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;21MGCAPSULE, EXTENDED RELEASE / ORALAB2025-02-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A208328-001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208328-002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;28MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208328-003MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;7MGCAPSULE, EXTENDED RELEASE / ORALAB2025-02-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208328-004MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;21MGCAPSULE, EXTENDED RELEASE / ORALAB2025-02-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208328-001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208328-002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;28MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208328-003MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;7MGCAPSULE, EXTENDED RELEASE / ORALAB2025-02-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208328-004MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;21MGCAPSULE, EXTENDED RELEASE / ORALAB2025-02-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208328-001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208328-002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;28MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208328-001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208328-002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;28MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208328-001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MGCAPSULE, EXTENDED RELEASE / ORAL2017-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208328-002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;28MGCAPSULE, EXTENDED RELEASE / ORAL2017-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208328-001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MGCAPSULE, EXTENDED RELEASE / ORAL2017-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208328-002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;28MGCAPSULE, EXTENDED RELEASE / ORAL2017-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208328-001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MGCAPSULE, EXTENDED RELEASE / ORAL2017-01-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208328-002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;28MGCAPSULE, EXTENDED RELEASE / ORAL2017-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208328-001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MGCAPSULE, EXTENDED RELEASE / ORAL2017-01-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A208328-002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;28MGCAPSULE, EXTENDED RELEASE / ORAL2017-01-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208328-001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MGCAPSULE, EXTENDED RELEASE / ORAL2017-01-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208328-002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;28MGCAPSULE, EXTENDED RELEASE / ORAL2017-01-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208328-001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MGCAPSULE, EXTENDED RELEASE / ORAL2017-01-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208328-002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;28MGCAPSULE, EXTENDED RELEASE / ORAL2017-01-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208328-001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MGCAPSULE, EXTENDED RELEASE / ORAL2017-01-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208328-002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;28MGCAPSULE, EXTENDED RELEASE / ORAL2017-01-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208328-001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MGCAPSULE, EXTENDED RELEASE / ORAL2017-01-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208328-002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;28MGCAPSULE, EXTENDED RELEASE / ORAL2017-01-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208328-001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MGCAPSULE, EXTENDED RELEASE / ORAL2017-01-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208328-002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;28MGCAPSULE, EXTENDED RELEASE / ORAL2017-01-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208328-001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MGCAPSULE, EXTENDED RELEASE / ORAL2017-01-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208328-002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;28MGCAPSULE, EXTENDED RELEASE / ORAL2017-01-275d02ea3f76ae…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208328-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208328-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208328-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208328-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208328-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208328-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208328-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208328-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208328-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208328-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208328-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208328-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208328-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208328-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208328-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208328-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208328-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208328-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208328-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208328-002AB103ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208328-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208328-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208328-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208328-004AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208328-001PC2025-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208328-002PC2025-07-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A208328-001PC2025-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208328-002PC2025-07-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208328-001PC2025-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208328-002PC2025-07-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208328-001PC2025-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208328-002PC2025-07-15b8a1b40f171c…

Additional Listing Data#

Finished product
Yes
Brand name base
Memantine and Donepezil Hydrochlorides Extended-release
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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d821427-34ca-3c5d-e063-6394a90a9013Available 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
73190-004-30Memantine and Donepezil Hydrochlorides Extended-release30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73190-004-30EA - Each73190-0047b82fa87-5cd1-4bb3-a847-358fc59d73f512025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73190-004MEMANTINE AND DONEPEZIL HYDROCHLORIDES EXTENDED-RELEASE (MEMANTINE AND DONEPEZIL) CAPSULE, EXTENDED RELEASE [AVKARE]1Current NDC, 1 package rows20250209_2d821427-34ca-3c5d-e063-6394a90a9013.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine and Donepezil Hydrochlorides Extended-releaseMEMANTINE AND DONEPEZILAvKARE2d821427-34ca-3c5d-e063-6394a90a90132025-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208328
application number: ANDA208328
ndc (package): 73190-004-30
ndc (product): 73190-004
ndc11 (package): 73190000430
Memantine and Donepezil Hydrochlorides Extended-releaseMEMANTINE AND DONEPEZILAmneal Pharmaceuticals NY LLC2335950c-be3b-4248-ad04-e9763aee47d22024-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208328
application number: ANDA208328

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1599803donepezil HCl 10 MG / memantine HCl 28 MG 24HR Extended Release Oral CapsulePSN2d821427-34ca-3c5d-e063-6394a90a90131
159980324 HR donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG Extended Release Oral CapsuleSCD2d821427-34ca-3c5d-e063-6394a90a90131
1599803donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSY2d821427-34ca-3c5d-e063-6394a90a90131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73190-004-307319000043030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (73190-004-30) 2025-02-06NoNoCurrent