Memantine Hydrochloride

Product NDC: 70436-054
11-digit product format: 704360054
Labeler code: 70436
Product ID: 70436-054_5003d132-8e5e-799f-e063-6394a90a5029
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: memantine hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Slate Run Pharmaceuticals, LLC
Application: ANDA211100
Marketing category: ANDA
Marketing start: 2021-11-15
Substance: MEMANTINE HYDROCHLORIDE
Active strength: 7 mg/1
Pharmacologic classes: 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

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
A211100-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02
A211100-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02
A211100-003	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02
A211100-004	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211100-001	AB
A211100-002	AB
A211100-003	AB
A211100-004	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 4 · 136 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	A211100-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211100-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211100-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211100-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211100-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211100-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211100-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211100-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211100-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211100-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211100-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211100-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211100-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211100-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211100-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211100-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211100-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211100-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211100-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211100-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211100-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211100-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211100-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211100-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211100-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211100-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211100-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211100-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211100-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211100-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211100-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211100-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211100-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211100-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211100-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211100-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211100-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211100-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211100-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211100-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 136 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	A211100-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211100-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211100-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211100-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211100-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211100-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211100-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211100-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211100-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211100-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211100-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211100-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211100-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211100-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211100-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211100-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211100-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211100-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211100-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211100-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211100-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211100-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211100-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211100-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211100-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211100-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211100-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211100-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211100-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211100-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211100-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211100-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211100-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211100-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211100-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211100-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211100-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211100-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211100-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211100-004	AB	1	`d06236e962d9…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MEMANTINE HYDROCHLORIDE	7 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
996594	Internal RxNorm lookup
996603	Internal RxNorm lookup
996609	Internal RxNorm lookup
996615	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
a74050c4-5a37-4fa1-85d9-85831525cfeb	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
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	Strength	SPL version
70436-054-04	Memantine Hydrochloride	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70436-054-04	EA - Each	70436-054	41802440-98f2-480e-8098-326de14850b7	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70436-054	MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SLATE RUN PHARMACEUTICALS, LLC]	14	Current NDC, Legacy NDC, 1 package rows	20250416_a74050c4-5a37-4fa1-85d9-85831525cfeb.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
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Slate Run Pharmaceuticals, LLC	a74050c4-5a37-4fa1-85d9-85831525cfeb	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211100 application number: ANDA211100 ndc (product): 70436-054

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
996594	memantine HCl 14 MG 24HR Extended Release Oral Capsule	PSN	a74050c4-5a37-4fa1-85d9-85831525cfeb	16
996603	memantine HCl 21 MG 24HR Extended Release Oral Capsule	PSN	a74050c4-5a37-4fa1-85d9-85831525cfeb	16
996609	memantine HCl 28 MG 24HR Extended Release Oral Capsule	PSN	a74050c4-5a37-4fa1-85d9-85831525cfeb	16
996615	memantine HCl 7 MG 24HR Extended Release Oral Capsule	PSN	a74050c4-5a37-4fa1-85d9-85831525cfeb	16
996594	24 HR memantine hydrochloride 14 MG Extended Release Oral Capsule	SCD	a74050c4-5a37-4fa1-85d9-85831525cfeb	16
996603	24 HR memantine hydrochloride 21 MG Extended Release Oral Capsule	SCD	a74050c4-5a37-4fa1-85d9-85831525cfeb	16
996609	24 HR memantine hydrochloride 28 MG Extended Release Oral Capsule	SCD	a74050c4-5a37-4fa1-85d9-85831525cfeb	16
996615	24 HR memantine hydrochloride 7 MG Extended Release Oral Capsule	SCD	a74050c4-5a37-4fa1-85d9-85831525cfeb	16
996594	memantine hydrochloride 14 MG 24 HR Extended Release Oral Capsule	SY	a74050c4-5a37-4fa1-85d9-85831525cfeb	16
996603	memantine hydrochloride 21 MG 24 HR Extended Release Oral Capsule	SY	a74050c4-5a37-4fa1-85d9-85831525cfeb	16
996609	memantine hydrochloride 28 MG 24 HR Extended Release Oral Capsule	SY	a74050c4-5a37-4fa1-85d9-85831525cfeb	16
996615	memantine hydrochloride 7 MG 24 HR Extended Release Oral Capsule	SY	a74050c4-5a37-4fa1-85d9-85831525cfeb	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70436-054-04	70436005404	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-054-04)	2021-11-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Memantine Hydrochloride	Slate Run Pharmaceuticals, LLC \| Yichang Humanwell Pharmaceutical Co., Ltd. \| Yichang Humanwell Oral Solid Dosage Plant	2026-04-21	HUMAN PRESCRIPTION DRUG LABEL	16