Namzaric

Product NDC: 0456-1228
11-digit product format: 004561228
Labeler code: 0456
Product ID: 0456-1228_00cae29c-d07a-484b-b279-be68f15c5e73
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: memantine hydrochloride and donepezil hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Allergan, Inc.
Application: NDA206439
Marketing category: NDA
Marketing start: 2014-12-24
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: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	0456-1228	0456-1228-11	D	Discontinued by firm	2026-08-17
excluded package	package	0456-1228	0456-1228-63	D	Discontinued by firm	2026-08-17
excluded package	package	0456-1228	0456-1228-90	D	Discontinued by firm	2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	RLD / RS	Approval date
N206439-001	NAMZARIC	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2014-12-23
N206439-002	NAMZARIC	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2014-12-23
N206439-003	NAMZARIC	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2016-07-18
N206439-004	NAMZARIC	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2016-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N206439-001	AB
N206439-002	AB
N206439-003	AB
N206439-004	AB

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206439-001	8039009	2029-03-24	U-1641
N206439-001	8039009*PED	2029-09-24		Pediatric extension
N206439-001	8058291	2029-12-05	U-1641		2015-01-22
N206439-002	8039009	2029-03-24	U-1641		2015-01-22
N206439-002	8039009*PED	2029-09-24		Pediatric extension
N206439-002	8058291	2029-12-05	U-1641		2015-01-22
N206439-003	8039009	2029-03-24	U-1641		2016-08-16
N206439-003	8039009*PED	2029-09-24		Pediatric extension
N206439-003	8058291	2029-12-05	U-1641		2016-08-16
N206439-004	8039009	2029-03-24	U-1641		2016-08-16
N206439-004	8039009*PED	2029-09-24		Pediatric extension
N206439-004	8058291	2029-12-05	U-1641		2016-08-16

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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N206439-001	NAMZARIC	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2014-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206439-002	NAMZARIC	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2014-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206439-003	NAMZARIC	10MG;7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2016-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206439-004	NAMZARIC	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2016-07-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206439-001	NAMZARIC	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2014-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206439-002	NAMZARIC	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2014-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206439-003	NAMZARIC	10MG;7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2016-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206439-004	NAMZARIC	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2016-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-001	NAMZARIC	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2014-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-002	NAMZARIC	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2014-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-003	NAMZARIC	10MG;7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2016-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-004	NAMZARIC	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2016-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206439-001	NAMZARIC	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2014-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206439-002	NAMZARIC	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2014-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206439-003	NAMZARIC	10MG;7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2016-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206439-004	NAMZARIC	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2016-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206439-001	NAMZARIC	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2014-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206439-002	NAMZARIC	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2014-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206439-003	NAMZARIC	10MG;7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2016-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206439-004	NAMZARIC	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2016-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206439-001	NAMZARIC	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2014-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206439-002	NAMZARIC	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2014-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206439-003	NAMZARIC	10MG;7MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2016-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206439-004	NAMZARIC	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2016-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206439-001	NAMZARIC	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2014-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206439-002	NAMZARIC	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2014-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206439-003	NAMZARIC	10MG;7MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2016-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206439-004	NAMZARIC	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2016-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206439-001	NAMZARIC	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2014-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206439-002	NAMZARIC	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2014-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206439-003	NAMZARIC	10MG;7MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2016-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206439-004	NAMZARIC	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2016-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206439-001	NAMZARIC	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2014-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206439-002	NAMZARIC	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2014-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206439-003	NAMZARIC	10MG;7MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2016-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206439-004	NAMZARIC	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2016-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206439-001	NAMZARIC	10MG;14MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2014-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206439-002	NAMZARIC	10MG;28MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2014-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206439-003	NAMZARIC	10MG;7MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2016-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206439-004	NAMZARIC	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2016-07-18	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N206439-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206439-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206439-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206439-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206439-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206439-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206439-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206439-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206439-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206439-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206439-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206439-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206439-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206439-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206439-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206439-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206439-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206439-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206439-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206439-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206439-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206439-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206439-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206439-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206439-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206439-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206439-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206439-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206439-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206439-004	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206439-004	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206439-004	AB	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N206439-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N206439-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N206439-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N206439-004	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 68 · 2,700 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N206439-001	8039009	2029-03-24	U-1641			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206439-001	8039009*PED	2029-09-24		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206439-001	8058291	2029-12-05	U-1641		2015-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206439-002	8039009	2029-03-24	U-1641		2015-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206439-002	8039009*PED	2029-09-24		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206439-002	8058291	2029-12-05	U-1641		2015-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206439-003	8039009	2029-03-24	U-1641		2016-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206439-003	8039009*PED	2029-09-24		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206439-003	8058291	2029-12-05	U-1641		2016-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206439-004	8039009	2029-03-24	U-1641		2016-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206439-004	8039009*PED	2029-09-24		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206439-004	8058291	2029-12-05	U-1641		2016-08-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206439-001	8039009	2029-03-24	U-1641			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206439-001	8039009*PED	2029-09-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206439-001	8058291	2029-12-05	U-1641		2015-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206439-002	8039009	2029-03-24	U-1641		2015-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206439-002	8039009*PED	2029-09-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206439-002	8058291	2029-12-05	U-1641		2015-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206439-003	8039009	2029-03-24	U-1641		2016-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206439-003	8039009*PED	2029-09-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206439-003	8058291	2029-12-05	U-1641		2016-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206439-004	8039009	2029-03-24	U-1641		2016-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206439-004	8039009*PED	2029-09-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206439-004	8058291	2029-12-05	U-1641		2016-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-001	8293794	2025-11-22		Drug product	2015-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-001	8338485	2025-11-22		Drug product	2016-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-001	8338486	2025-11-22	U-1641		2016-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-001	8580858	2025-11-22	U-1641		2016-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-001	8039009	2029-03-24	U-1641			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-001	8039009*PED	2029-09-24		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-001	8058291	2029-12-05	U-1641		2015-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-002	8293794	2025-11-22		Drug product	2015-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-002	8338485	2025-11-22		Drug product	2015-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-002	8338486	2025-11-22	U-1641		2015-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-002	8580858	2025-11-22	U-1641		2015-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-002	8039009	2029-03-24	U-1641		2015-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-002	8039009*PED	2029-09-24		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-002	8058291	2029-12-05	U-1641		2015-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-003	8293794	2025-11-22		Drug product	2016-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206439-003	8338485	2025-11-22		Drug product	2016-08-16	`31067a03dcf5…`

Additional Listing Data#

Finished product: Yes
Brand name base: Namzaric
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MEMANTINE HYDROCHLORIDE	28 mg/1
DONEPEZIL HYDROCHLORIDE	10 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 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1599803	Internal RxNorm lookup
1599805	Internal RxNorm lookup
1602588	Internal RxNorm lookup
1602594	Internal RxNorm lookup
1805420	Internal RxNorm lookup
1805422	Internal RxNorm lookup
1805425	Internal RxNorm lookup
1805427	Internal RxNorm lookup
1858970	Internal RxNorm lookup
1858971	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
90fedc32-19e5-480c-afc6-f35a5cf4b9aa	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
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	SPL version
0456-1228-11	Namzaric	10 in 1 BLISTER PACK	CAPSULE	10	23
0456-1228-30	Namzaric	30 in 1 BOTTLE	CAPSULE	30	23
0456-1228-63	Namzaric	10 in 1 BLISTER PACK	CAPSULE	10	23
0456-1228-63	Namzaric	10 in 1 CARTON	CAPSULE	10	23
0456-1228-90	Namzaric	90 in 1 BOTTLE	CAPSULE	90	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0456-1228-30	EA - Each	0456-1228	c88e4551-3de7-4e1d-88fc-b0089b294dfd	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
donepezil hydrochloride	ACTIVE INGREDIENT	3O2T2PJ89D	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5
memantine hydrochloride	ACTIVE INGREDIENT	JY0WD0UA60	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5
donepezil	ACTIVE MOIETY	8SSC91326P	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5
memantine	ACTIVE MOIETY	W8O17SJF3T	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5
ethylcelluloses	INACTIVE INGREDIENT	7Z8S9VYZ4B	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5
gelatin	INACTIVE INGREDIENT	2G86QN327L	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5
medium-chain triglycerides	INACTIVE INGREDIENT	C9H2L21V7U	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5
oleic acid	INACTIVE INGREDIENT	2UMI9U37CP	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5
povidones	INACTIVE INGREDIENT	FZ989GH94E	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5
shellac	INACTIVE INGREDIENT	46N107B71O	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5
sucrose	INACTIVE INGREDIENT	C151H8M554	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5
talc	INACTIVE INGREDIENT	7SEV7J4R1U	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE [FOREST LABORATORIES, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0456-1228	NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) KIT [ALLERGAN, INC.]	20	Current NDC, Legacy NDC, 5 package rows	20241109_90fedc32-19e5-480c-afc6-f35a5cf4b9aa.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Namzaric	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	Allergan, Inc.	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206439 application number: NDA206439 ndc (product): 0456-1228

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
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]	BPCK	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
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) } Pack	GPCK	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1599805	donepezil HCl 10 MG / memantine HCl 14 MG 24HR Extended Release Oral Capsule	PSN	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1805420	donepezil HCl 10 MG / memantine HCl 21 MG 24HR Extended Release Oral Capsule	PSN	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1599803	donepezil HCl 10 MG / memantine HCl 28 MG 24HR Extended Release Oral Capsule	PSN	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1805425	donepezil HCl 10 MG / memantine HCl 7 MG 24HR Extended Release Oral Capsule	PSN	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1858970	memantine 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 Pack	PSN	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1602588	Namzaric 14 MG / 10 MG 24HR Extended Release Oral Capsule	PSN	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1805422	Namzaric 21 MG / 10 MG 24HR Extended Release Oral Capsule	PSN	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1602594	Namzaric 28 MG / 10 MG 24HR Extended Release Oral Capsule	PSN	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1805427	Namzaric 7 MG / 10 MG 24HR Extended Release Oral Capsule	PSN	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1858971	Namzaric Titration Pack	PSN	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1602588	24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 14 MG Extended Release Oral Capsule [Namzaric]	SBD	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1805422	24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 21 MG Extended Release Oral Capsule [Namzaric]	SBD	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1602594	24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG Extended Release Oral Capsule [Namzaric]	SBD	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1805427	24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 7 MG Extended Release Oral Capsule [Namzaric]	SBD	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1599805	24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 14 MG Extended Release Oral Capsule	SCD	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1805420	24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 21 MG Extended Release Oral Capsule	SCD	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1599803	24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG Extended Release Oral Capsule	SCD	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1805425	24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 7 MG Extended Release Oral Capsule	SCD	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1599805	donepezil hydrochloride 10 MG / memantine hydrochloride 14 MG 24 HR Extended Release Oral Capsule	SY	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1805420	donepezil hydrochloride 10 MG / memantine hydrochloride 21 MG 24HR Extended Release Oral Capsule	SY	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1599803	donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG 24 HR Extended Release Oral Capsule	SY	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1805425	donepezil hydrochloride 10 MG / memantine hydrochloride 7 MG 24HR Extended Release Oral Capsule	SY	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1858970	memantine and donepezil hydrochlorides titration pack	SY	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1602588	Namzaric (donepezil HCl 10 MG / memantine HCl 14 MG) 24 HR Extended Release Oral Capsule	SY	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1805422	Namzaric (donepezil HCl 10 MG / memantine HCl 21 MG) 24 HR Extended Release Oral Capsule	SY	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1602594	Namzaric (donepezil HCl 10 MG / memantine HCl 28 MG) 24 HR Extended Release Oral Capsule	SY	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1805427	Namzaric (donepezil HCl 10 MG / memantine HCl 7 MG) 24 HR Extended Release Oral Capsule	SY	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23
1858971	Namzaric Titration Pack	SY	90fedc32-19e5-480c-afc6-f35a5cf4b9aa	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0456-1228-11	00456122811	10 CAPSULE in 1 BLISTER PACK (0456-1228-11)	10 capsule	2014-12-24	0000-00-00	No	No	Current
0456-1228-30	00456122830	30 CAPSULE in 1 BOTTLE (0456-1228-30)	30 capsule	2014-12-24	0000-00-00	No	No	Current
0456-1228-63	00456122863	10 in 1 BLISTER PACK						Historical
0456-1228-90	00456122890	90 in 1 BOTTLE						Historical