Memantine Hydrochloride

Product NDC: 68788-7730
Requested package NDC: 68788-7730-3
11-digit product format: 687887730
Labeler code: 68788
Product ID: 68788-7730_c3ea76f9-be74-4c87-87b6-39a7523b1eec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Memantine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA090961
Marketing category: ANDA
Marketing start: 2020-07-01
Marketing end: 0000-00-00
Substance: MEMANTINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-7730	68788-7730-3	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7730	68788-7730-3	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7730	68788-7730-3	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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-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 · 82 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	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…`
2021-12-28 21:50 UTC	2021-12	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2021-12-28 21:50 UTC	2021-12	A090961-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090961-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7730-3	EA - Each	68788-7730	470495eb-468d-45c2-ae7b-3959e9e10812	1	2020-09-14
68788-7730-6	EA - Each	68788-7730	af510cd5-e9bd-4cfe-989a-0997d8fc7757	1	2020-09-14
68788-7730-9	EA - Each	68788-7730	2f989085-a1b6-4996-aa94-179d22a8fb6a	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7730	MEMANTINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	5	Legacy NDC	20240704_6c03a58c-7734-4b6f-9528-ccc8fac196a7.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	2026-04-08	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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7730-3	68788773003	30 TABLET in 1 BOTTLE (68788-7730-3)	30 tablet	2020-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Memantine Hydrochloride	Preferred Pharmaceuticals, Inc.	2024-07-03	HUMAN PRESCRIPTION DRUG LABEL	5