Memantine Hydrochloride

Product NDC: 16571-853
11-digit product format: 165710853
Labeler code: 16571
Product ID: 16571-853_4ece2bda-d26f-494f-93df-bc53c494caf9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: memantine
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA206032
Marketing category: ANDA
Marketing start: 2025-06-01
Substance: MEMANTINE HYDROCHLORIDE
Active strength: 14 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 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
A206032-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28
A206032-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28
A206032-003	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28
A206032-004	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206032-001	AB
A206032-002	AB
A206032-003	AB
A206032-004	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 5 · 164 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	A206032-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206032-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206032-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206032-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206032-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206032-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206032-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206032-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206032-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206032-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206032-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206032-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206032-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206032-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206032-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206032-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206032-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206032-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206032-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206032-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206032-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206032-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206032-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206032-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206032-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206032-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206032-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206032-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206032-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206032-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206032-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206032-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206032-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206032-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206032-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206032-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206032-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206032-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206032-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206032-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 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	A206032-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206032-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206032-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206032-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206032-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206032-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206032-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206032-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206032-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206032-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206032-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206032-004	AB	1	`6a471c1ec25d…`
2019-12-13 00:20 UTC	2019-12	A206032-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206032-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206032-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206032-004	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206032-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206032-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206032-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206032-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206032-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206032-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206032-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206032-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206032-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206032-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206032-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206032-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206032-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206032-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206032-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206032-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206032-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206032-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206032-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206032-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206032-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206032-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206032-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206032-004	AB	1	`b00525d2431f…`

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	14 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
a282fbed-8304-458e-a0e9-5eaccc95339b	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
16571-853-03	Memantine Hydrochloride	30 in 1 BOTTLE, PLASTIC	CAPSULE, EXTENDED RELEASE	30		3
16571-853-09	Memantine Hydrochloride	90 in 1 BOTTLE, PLASTIC	CAPSULE, EXTENDED RELEASE	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-853-03	EA - Each	16571-853	5da7a748-8ddd-4e78-bb00-5e9bbef6492a	1	2025-09-12
16571-853-09	EA - Each	16571-853	1bdc116e-32d3-4cb6-acfb-4ac0ee7ee892	1	2025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-853	MEMANTINE HYDROCHLORIDE (MEMANTINE) CAPSULE, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.]	2	Current NDC, 2 package rows	20250424_a282fbed-8304-458e-a0e9-5eaccc95339b.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	Rising Pharma Holdings, Inc.	a282fbed-8304-458e-a0e9-5eaccc95339b	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206032 application number: ANDA206032 ndc (product): 16571-853

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JY0WD0UA60	MEMANTINE HYDROCHLORIDE	41100-52-1	MEMANTINE HYDROCHLORIDE
W8O17SJF3T	MEMANTINE	19982-08-2	memantine

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	a282fbed-8304-458e-a0e9-5eaccc95339b	3
996603	memantine HCl 21 MG 24HR Extended Release Oral Capsule	PSN	a282fbed-8304-458e-a0e9-5eaccc95339b	3
996609	memantine HCl 28 MG 24HR Extended Release Oral Capsule	PSN	a282fbed-8304-458e-a0e9-5eaccc95339b	3
996615	memantine HCl 7 MG 24HR Extended Release Oral Capsule	PSN	a282fbed-8304-458e-a0e9-5eaccc95339b	3
996594	24 HR memantine hydrochloride 14 MG Extended Release Oral Capsule	SCD	a282fbed-8304-458e-a0e9-5eaccc95339b	3
996603	24 HR memantine hydrochloride 21 MG Extended Release Oral Capsule	SCD	a282fbed-8304-458e-a0e9-5eaccc95339b	3
996609	24 HR memantine hydrochloride 28 MG Extended Release Oral Capsule	SCD	a282fbed-8304-458e-a0e9-5eaccc95339b	3
996615	24 HR memantine hydrochloride 7 MG Extended Release Oral Capsule	SCD	a282fbed-8304-458e-a0e9-5eaccc95339b	3
996594	memantine hydrochloride 14 MG 24 HR Extended Release Oral Capsule	SY	a282fbed-8304-458e-a0e9-5eaccc95339b	3
996603	memantine hydrochloride 21 MG 24 HR Extended Release Oral Capsule	SY	a282fbed-8304-458e-a0e9-5eaccc95339b	3
996609	memantine hydrochloride 28 MG 24 HR Extended Release Oral Capsule	SY	a282fbed-8304-458e-a0e9-5eaccc95339b	3
996615	memantine hydrochloride 7 MG 24 HR Extended Release Oral Capsule	SY	a282fbed-8304-458e-a0e9-5eaccc95339b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
16571-853-03	16571085303	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16571-853-03)	2025-06-01	No	No	Current
16571-853-09	16571085309	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16571-853-09)	2025-06-01	No	No	Current