Memantine and Donepezil Hydrochlorides Extended-release

Product NDC: 69238-1247
11-digit product format: 692381247
Labeler code: 69238
Product ID: 69238-1247_acd577e1-312c-4d5a-85b5-bc50ef9de545
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Memantine and Donepezil
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA208328
Marketing category: ANDA
Marketing start: 2017-02-01
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208328-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-01-27
A208328-002	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-01-27
A208328-003	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2025-02-27
A208328-004	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2025-02-27

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208328-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208328-002	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208328-003	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2025-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208328-004	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2025-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208328-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208328-002	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208328-003	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2025-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208328-004	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2025-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208328-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208328-002	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208328-003	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2025-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208328-004	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2025-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208328-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208328-002	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208328-003	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2025-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208328-004	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2025-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208328-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208328-002	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208328-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208328-002	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208328-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208328-002	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208328-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208328-002	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208328-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208328-002	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208328-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208328-002	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208328-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-01-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208328-002	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208328-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-01-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208328-002	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208328-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-01-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208328-002	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208328-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-01-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208328-002	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208328-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-01-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208328-002	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208328-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-01-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208328-002	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-01-27	`5d02ea3f76ae…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208328-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208328-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208328-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208328-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208328-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208328-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208328-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208328-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208328-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208328-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208328-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208328-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208328-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208328-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208328-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208328-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208328-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208328-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208328-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208328-002	AB	1	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208328-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208328-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208328-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208328-004	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208328-001	PC	2025-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208328-002	PC	2025-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208328-001	PC	2025-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208328-002	PC	2025-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208328-001	PC	2025-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208328-002	PC	2025-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208328-001	PC	2025-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208328-002	PC	2025-07-15	`b8a1b40f171c…`

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
Ingredient	Strength
MEMANTINE HYDROCHLORIDE	10 mg/1
DONEPEZIL HYDROCHLORIDE	28 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JY0WD0UA60	Internal UNII lookup
3O2T2PJ89D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1599803	Internal RxNorm lookup
1599805	Internal RxNorm lookup
1805420	Internal RxNorm lookup
1805425	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
2335950c-be3b-4248-ad04-e9763aee47d2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
94db636e-a074-45fd-8e8d-331920a99436	Product name	4	20250103
941773f8-a40e-0684-da08-ff9a143e6368	Product name	7	20231219
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7	Product name	1	20221214
5b597f00-4538-4686-aa4e-3c60ed3788c8	Product name	2	20210511
d7e50b51-94ef-29ef-8273-837d555048c1	Product name	9	20160811
1836e79a-a4d1-4087-2f2e-f878e8a1fef2	Product name	9	20151209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69238-1247-3	Memantine and Donepezil Hydrochlorides Extended-release	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30		16
69238-1247-9	Memantine and Donepezil Hydrochlorides Extended-release	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69238-1247-3	EA - Each	69238-1247	ba98f13e-5937-4797-a340-e40acc9e4fea	1	2025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-1247	MEMANTINE AND DONEPEZIL HYDROCHLORIDES EXTENDED-RELEASE (MEMANTINE AND DONEPEZIL) CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS NY LLC]	16	Current NDC, Legacy NDC, 2 package rows	20250302_2335950c-be3b-4248-ad04-e9763aee47d2.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Memantine and Donepezil Hydrochlorides Extended-release	MEMANTINE AND DONEPEZIL	AvKARE	2d821427-34ca-3c5d-e063-6394a90a9013	2025-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208328 application number: ANDA208328
Memantine and Donepezil Hydrochlorides Extended-release	MEMANTINE AND DONEPEZIL	Amneal Pharmaceuticals NY LLC	2335950c-be3b-4248-ad04-e9763aee47d2	2024-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208328 application number: ANDA208328 ndc (product): 69238-1247

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3O2T2PJ89D	DONEPEZIL HYDROCHLORIDE	120011-70-3	DONEPEZIL HYDROCHLORIDE
JY0WD0UA60	MEMANTINE HYDROCHLORIDE	41100-52-1	MEMANTINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1599805	donepezil HCl 10 MG / memantine HCl 14 MG 24HR Extended Release Oral Capsule	PSN	2335950c-be3b-4248-ad04-e9763aee47d2	16
1805420	donepezil HCl 10 MG / memantine HCl 21 MG 24HR Extended Release Oral Capsule	PSN	2335950c-be3b-4248-ad04-e9763aee47d2	16
1599803	donepezil HCl 10 MG / memantine HCl 28 MG 24HR Extended Release Oral Capsule	PSN	2335950c-be3b-4248-ad04-e9763aee47d2	16
1805425	donepezil HCl 10 MG / memantine HCl 7 MG 24HR Extended Release Oral Capsule	PSN	2335950c-be3b-4248-ad04-e9763aee47d2	16
1599805	24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 14 MG Extended Release Oral Capsule	SCD	2335950c-be3b-4248-ad04-e9763aee47d2	16
1805420	24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 21 MG Extended Release Oral Capsule	SCD	2335950c-be3b-4248-ad04-e9763aee47d2	16
1599803	24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG Extended Release Oral Capsule	SCD	2335950c-be3b-4248-ad04-e9763aee47d2	16
1805425	24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 7 MG Extended Release Oral Capsule	SCD	2335950c-be3b-4248-ad04-e9763aee47d2	16
1599805	donepezil hydrochloride 10 MG / memantine hydrochloride 14 MG 24 HR Extended Release Oral Capsule	SY	2335950c-be3b-4248-ad04-e9763aee47d2	16
1805420	donepezil hydrochloride 10 MG / memantine hydrochloride 21 MG 24HR Extended Release Oral Capsule	SY	2335950c-be3b-4248-ad04-e9763aee47d2	16
1599803	donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG 24 HR Extended Release Oral Capsule	SY	2335950c-be3b-4248-ad04-e9763aee47d2	16
1805425	donepezil hydrochloride 10 MG / memantine hydrochloride 7 MG 24HR Extended Release Oral Capsule	SY	2335950c-be3b-4248-ad04-e9763aee47d2	16
1599803	donepezil HCl 10 MG / memantine HCl 28 MG 24HR Extended Release Oral Capsule	PSN	2d821427-34ca-3c5d-e063-6394a90a9013	1
1599803	24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG Extended Release Oral Capsule	SCD	2d821427-34ca-3c5d-e063-6394a90a9013	1
1599803	donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG 24 HR Extended Release Oral Capsule	SY	2d821427-34ca-3c5d-e063-6394a90a9013	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69238-1247-3	69238124703	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1247-3)	2017-02-01	0000-00-00	No	No	Current
69238-1247-9	69238124709	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1247-9)	2017-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Memantine and Donepezil Hydrochlorides Extended-release	AvKARE	2025-02-06	HUMAN PRESCRIPTION DRUG LABEL	1
Memantine and Donepezil Hydrochlorides Extended-release	Amneal Pharmaceuticals NY LLC	2024-12-17	HUMAN PRESCRIPTION DRUG LABEL	16