Memantine Hydrochloride

Product NDC: 72578-003
11-digit product format: 725780003
Labeler code: 72578
Product ID: 72578-003_2dee57d8-27d7-481c-b1c9-21375e258a1b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Memantine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Viona Pharmaceuticals Inc
Application: ANDA090961
Marketing category: ANDA
Marketing start: 2019-02-28
Substance: MEMANTINE HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: 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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090961-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-07-10
A090961-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2017-07-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090961-001	AB
A090961-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090961-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090961-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090961-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090961-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090961-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090961-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090961-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090961-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090961-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090961-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090961-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090961-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090961-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090961-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090961-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090961-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090961-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090961-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090961-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090961-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090961-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090961-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090961-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090961-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090961-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090961-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090961-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090961-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090961-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090961-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090961-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090961-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090961-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090961-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090961-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090961-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090961-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090961-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090961-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090961-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Memantine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MEMANTINE HYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
996561	Internal RxNorm lookup
996571	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
dcbdb62a-a4e2-4058-b73c-46005f2a5d51	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
5b597f00-4538-4686-aa4e-3c60ed3788c8	Product name	2	20210511
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
72578-003-01	Memantine Hydrochloride	100 in 1 BOTTLE	TABLET	100	3
72578-003-05	Memantine Hydrochloride	500 in 1 BOTTLE	TABLET	500	3
72578-003-10	Memantine Hydrochloride	1000 in 1 BOTTLE	TABLET	1000	3
72578-003-14	Memantine Hydrochloride	60 in 1 BOTTLE	TABLET	60	3
72578-003-30	Memantine Hydrochloride	10 in 1 BLISTER PACK	TABLET	10	3
72578-003-77	Memantine Hydrochloride	10 in 1 CARTON	TABLET	10	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72578-003-05	EA - Each	72578-003	f79da0f8-9c50-4ea5-9b68-363c288fdc8c	1	2019-12-10
72578-003-14	EA - Each	72578-003	ccf1ab2d-7b91-45c0-9d66-315d15cdc96e	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72578-003	MEMANTINE HYDROCHLORIDE TABLET [VIONA PHARMACEUTICALS INC]	3	Current NDC, Legacy NDC, 6 package rows	20221014_dcbdb62a-a4e2-4058-b73c-46005f2a5d51.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	REMEDYREPACK INC.	cbfd9d95-f50b-45ff-9857-9f1712c45e56	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	DirectRx	d0839a2d-35f1-1f14-e053-2995a90ad549	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3662b11a-354a-b683-e063-6394a90a0086	2025-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Coupler LLC	2d54be77-75b2-76b3-e063-6294a90a0cc0	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Zydus Lifesciences Limited	514421f3-f525-43e8-aecc-8b2bbffd00dc	2024-08-16		Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	A-S Medication Solutions	f05e381f-850d-42ea-9dd8-6d1f8dac4f62	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	0ad2246a-ffa0-43a0-8094-58279d3e3a74	2024-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	be919d34-e9f4-49c8-8145-2dcafb7cb88c	2024-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	9cfddd01-6e1d-4ee0-9310-3fb371724e3d	2023-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	bf395152-2885-4633-bf3f-2da46e7b79f1	2023-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	8bd5b908-f46a-4ced-9408-45984d716149	2023-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe0	2023-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	54a12ddf-306b-4eb7-a7c3-c7b58df3b372	2023-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	fac8c59b-5bf5-478e-8223-a5ecaa400625	2023-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	c8f96b24-de66-4a17-b798-42b42a25e84c	2023-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Viona Pharmaceuticals Inc	dcbdb62a-a4e2-4058-b73c-46005f2a5d51	2022-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961 ndc (product): 72578-003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JY0WD0UA60	MEMANTINE HYDROCHLORIDE	41100-52-1	MEMANTINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
996571	memantine HCl 5 MG Oral Tablet	PSN	9cfddd01-6e1d-4ee0-9310-3fb371724e3d	103
996571	memantine hydrochloride 5 MG Oral Tablet	SCD	9cfddd01-6e1d-4ee0-9310-3fb371724e3d	103
996571	memantine HCl 5 MG Oral Tablet	PSN	2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe0	102
996571	memantine HCl 5 MG Oral Tablet	PSN	fac8c59b-5bf5-478e-8223-a5ecaa400625	102
996571	memantine hydrochloride 5 MG Oral Tablet	SCD	2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe0	102
996571	memantine hydrochloride 5 MG Oral Tablet	SCD	fac8c59b-5bf5-478e-8223-a5ecaa400625	102
996571	memantine HCl 5 MG Oral Tablet	PSN	8bd5b908-f46a-4ced-9408-45984d716149	101
996571	memantine hydrochloride 5 MG Oral Tablet	SCD	8bd5b908-f46a-4ced-9408-45984d716149	101
996571	memantine HCl 5 MG Oral Tablet	PSN	0ad2246a-ffa0-43a0-8094-58279d3e3a74	100
996571	memantine hydrochloride 5 MG Oral Tablet	SCD	0ad2246a-ffa0-43a0-8094-58279d3e3a74	100
996571	memantine HCl 5 MG Oral Tablet	PSN	cbfd9d95-f50b-45ff-9857-9f1712c45e56	7
996571	memantine hydrochloride 5 MG Oral Tablet	SCD	cbfd9d95-f50b-45ff-9857-9f1712c45e56	7
996571	memantine HCl 5 MG Oral Tablet	PSN	f05e381f-850d-42ea-9dd8-6d1f8dac4f62	6
996571	memantine hydrochloride 5 MG Oral Tablet	SCD	f05e381f-850d-42ea-9dd8-6d1f8dac4f62	6
996571	memantine HCl 5 MG Oral Tablet	PSN	d0839a2d-35f1-1f14-e053-2995a90ad549	4
996571	memantine hydrochloride 5 MG Oral Tablet	SCD	d0839a2d-35f1-1f14-e053-2995a90ad549	4
996561	memantine HCl 10 MG Oral Tablet	PSN	dcbdb62a-a4e2-4058-b73c-46005f2a5d51	3
996571	memantine HCl 5 MG Oral Tablet	PSN	dcbdb62a-a4e2-4058-b73c-46005f2a5d51	3
996561	memantine hydrochloride 10 MG Oral Tablet	SCD	dcbdb62a-a4e2-4058-b73c-46005f2a5d51	3
996571	memantine hydrochloride 5 MG Oral Tablet	SCD	dcbdb62a-a4e2-4058-b73c-46005f2a5d51	3
996571	memantine HCl 5 MG Oral Tablet	PSN	3662b11a-354a-b683-e063-6394a90a0086	1
996571	memantine HCl 5 MG Oral Tablet	PSN	2d54be77-75b2-76b3-e063-6294a90a0cc0	1
996571	memantine hydrochloride 5 MG Oral Tablet	SCD	3662b11a-354a-b683-e063-6394a90a0086	1
996571	memantine hydrochloride 5 MG Oral Tablet	SCD	2d54be77-75b2-76b3-e063-6294a90a0cc0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72578-003-01	72578000301	100 TABLET in 1 BOTTLE (72578-003-01)	100 tablet	2019-02-28	0000-00-00	No	No	Current
72578-003-05	72578000305	500 TABLET in 1 BOTTLE (72578-003-05)	500 tablet	2019-02-28	0000-00-00	No	No	Current
72578-003-10	72578000310	1000 TABLET in 1 BOTTLE (72578-003-10)	1000 tablet	2019-02-28	0000-00-00	No	No	Current
72578-003-14	72578000314	60 TABLET in 1 BOTTLE (72578-003-14)	60 tablet	2019-02-28	0000-00-00	No	No	Current
72578-003-30	72578000330	10 in 1 BLISTER PACK						Historical
72578-003-77	72578000377	10 BLISTER PACK in 1 CARTON (72578-003-77) / 10 TABLET in 1 BLISTER PACK (72578-003-30)	10 blister pack	2019-02-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Memantine Hydrochloride	REMEDYREPACK INC.	2026-08-06	HUMAN PRESCRIPTION DRUG LABEL	8
Memantine HCL	DirectRx	2026-03-06	HUMAN PRESCRIPTION DRUG LABEL	4
Memantine Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2025-05-30	HUMAN PRESCRIPTION DRUG LABEL	1
Memantine Hydrochloride	Coupler LLC \| Zydus Lifesciences Limited	2025-02-04	HUMAN PRESCRIPTION DRUG LABEL	1
Memantine Hydrochloride	A-S Medication Solutions	2024-05-30	HUMAN PRESCRIPTION DRUG LABEL	6
Memantine Hydrochloride	Bryant Ranch Prepack	2024-02-06	HUMAN PRESCRIPTION DRUG LABEL	100
Memantine Hydrochloride	Bryant Ranch Prepack	2023-10-04	HUMAN PRESCRIPTION DRUG LABEL	103
Memantine Hydrochloride	Bryant Ranch Prepack	2023-03-24	HUMAN PRESCRIPTION DRUG LABEL	101
Memantine Hydrochloride	Bryant Ranch Prepack	2023-03-03	HUMAN PRESCRIPTION DRUG LABEL	102
Memantine Hydrochloride	Bryant Ranch Prepack	2023-03-03	HUMAN PRESCRIPTION DRUG LABEL	102
Memantine Hydrochloride	Viona Pharmaceuticals Inc \| Zydus Lifesciences Limited	2022-10-08	HUMAN PRESCRIPTION DRUG LABEL	3