Amantadine

Product NDC: 0615-8605
11-digit product format: 006158605
Labeler code: 0615
Product ID: 0615-8605_a8ae3043-8fe8-4e56-9829-a53b597c4910
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amantadine
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: ANDA214284
Marketing category: ANDA
Marketing start: 2020-10-20
Substance: AMANTADINE HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214284-001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2020-10-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214284-001	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.

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	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214284-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-15	`a50c72e98297…`

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	A214284-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214284-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214284-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214284-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214284-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214284-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214284-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214284-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214284-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214284-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214284-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214284-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214284-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214284-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214284-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214284-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214284-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214284-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214284-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214284-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214284-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214284-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A214284-001	AB	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214284-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214284-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214284-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214284-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214284-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214284-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214284-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214284-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214284-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214284-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214284-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214284-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214284-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214284-001	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMANTADINE HYDROCHLORIDE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
M6Q1EO9TD0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
849395	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
2ff05131-f634-4688-86e9-9bc33a8d11c4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
519d6abc-639d-2962-cced-abbf8b16aad4	Product name	7	20250401
82f46845-b4c7-48da-a389-ba5721b956c9	Product name	2	20250325
d2c037c0-5ebf-d224-252f-2549922c21c7	Product name	7	20240208
b7b57a62-2f7f-1a22-2cb2-eaa5c08d4721	Product name	2	20220224
14e11aaf-885f-472f-a02a-c6a3f28df907	Product name	1	20180515
82f46845-b4c7-48da-a389-ba5721b956c9	Product name	1	20171103

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0615-8605-39	Amantadine	30 in 1 BLISTER PACK	TABLET	30		1

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amantadine	AMANTADINE	Proficient Rx LP	7aa6bc18-1cee-4b6d-b7c3-0bac6a924ece	2026-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214284 application number: ANDA214284
Amantadine	AMANTADINE	NCS HealthCare of KY, LLC dba Vangard Labs	2ff05131-f634-4688-86e9-9bc33a8d11c4	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214284 application number: ANDA214284 ndc (product): 0615-8605
Amantadine	AMANTADINE	Alembic Pharmaceuticals Inc.	da1837b5-fda2-48e0-91ba-d6eb2b991b55	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214284 application number: ANDA214284
Amantadine	AMANTADINE	Coupler LLC	303c5b9d-5761-9fcd-e063-6394a90a8a2b	2025-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214284 application number: ANDA214284
Amantadine	AMANTADINE	Alembic Pharmaceuticals Limited	48fa07c8-8b95-40d7-a0f5-132577dfb2c8	2023-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214284 application number: ANDA214284

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M6Q1EO9TD0	AMANTADINE HYDROCHLORIDE	665-66-7	AMANTADINE HYDROCHLORIDE
BF4C9Z1J53	AMANTADINE	768-94-5	Amantadine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
849395	amantadine HCl 100 MG Oral Tablet	PSN	2ff05131-f634-4688-86e9-9bc33a8d11c4	1
849395	amantadine hydrochloride 100 MG Oral Tablet	SCD	2ff05131-f634-4688-86e9-9bc33a8d11c4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0615-8605-39	00615860539	30 TABLET in 1 BLISTER PACK (0615-8605-39)	30 tablet	2026-01-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amantadine Hydrochloride Tablets, USP Rx only	NCS HealthCare of KY, LLC dba Vangard Labs	2026-01-23	HUMAN PRESCRIPTION DRUG LABEL	1