Amantadine Hydrochloride

Product NDC: 42543-497
11-digit product format: 425430497
Labeler code: 42543
Product ID: 42543-497_0b366abe-58d8-43b8-8d0e-3659aad1c4af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amantadine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Strides Pharma Inc.
Application: ANDA209035
Marketing category: ANDA
Marketing start: 2017-08-04
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
A209035-001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209035-001	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.

Product history page 1 of 2 · 42 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	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	BX	2017-06-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	BX	2017-06-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	BX	2017-06-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	BX	2017-06-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	BX	2017-06-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-06-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	BX	2017-06-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	BX	2017-06-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	BX	2017-06-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209035-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	BX	2017-06-09	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A209035-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209035-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209035-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209035-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209035-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209035-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209035-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209035-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209035-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209035-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209035-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209035-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209035-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209035-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209035-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209035-001	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209035-001	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209035-001	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209035-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209035-001	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209035-001	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209035-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209035-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209035-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209035-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209035-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209035-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209035-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209035-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209035-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209035-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209035-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209035-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209035-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209035-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209035-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209035-001	BX	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209035-001	BX	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209035-001	BX	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209035-001	BX	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Amantadine Hydrochloride
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
9a99bb98-82a4-4b9e-9216-554dade72a3c	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
42543-497-01	Amantadine Hydrochloride	100 in 1 BOTTLE	TABLET	100		8
42543-497-05	Amantadine Hydrochloride	500 in 1 BOTTLE	TABLET	500		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42543-497-01	EA - Each	42543-497	4f226166-9372-474e-b3e4-31c9604d2efc	1	2017-08-11
42543-497-05	EA - Each	42543-497	6edda662-80e3-4934-aef0-41509aed2bab	1	2017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42543-497	AMANTADINE HYDROCHLORIDE TABLET [STRIDES PHARMA INC.]	7	Current NDC, Legacy NDC, 2 package rows	20240620_9a99bb98-82a4-4b9e-9216-554dade72a3c.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Strides Pharma Inc.	9a99bb98-82a4-4b9e-9216-554dade72a3c	2025-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209035 application number: ANDA209035 ndc (product): 42543-497
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Coupler LLC	2d94073b-c064-c280-e063-6294a90af145	2025-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209035 application number: ANDA209035
Amantadine HCL	AMANTADINE HCL	Direct_Rx	1211ebf4-3169-20ca-e063-6294a90aee4d	2024-02-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209035 application number: ANDA209035

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M6Q1EO9TD0	AMANTADINE HYDROCHLORIDE	665-66-7	AMANTADINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
849395	amantadine HCl 100 MG Oral Tablet	PSN	9a99bb98-82a4-4b9e-9216-554dade72a3c	8
849395	amantadine hydrochloride 100 MG Oral Tablet	SCD	9a99bb98-82a4-4b9e-9216-554dade72a3c	8
849395	amantadine HCl 100 MG Oral Tablet	PSN	1211ebf4-3169-20ca-e063-6294a90aee4d	4
849395	amantadine hydrochloride 100 MG Oral Tablet	SCD	1211ebf4-3169-20ca-e063-6294a90aee4d	4
849395	amantadine HCl 100 MG Oral Tablet	PSN	2d94073b-c064-c280-e063-6294a90af145	1
849395	amantadine hydrochloride 100 MG Oral Tablet	SCD	2d94073b-c064-c280-e063-6294a90af145	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42543-497-01	42543049701	100 TABLET in 1 BOTTLE (42543-497-01)	100 tablet	2017-08-04	0000-00-00	No	No	Current
42543-497-05	42543049705	500 TABLET in 1 BOTTLE (42543-497-05)	500 tablet	2017-08-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amantadine Hydrochloride Tablets	Strides Pharma Inc. \| Strides Pharma Science Limited \| Strides Alathur Private Limited	2025-12-12	HUMAN PRESCRIPTION DRUG LABEL	8
Amantadine Hydrochloride Tablets	Coupler LLC	2025-02-07	HUMAN PRESCRIPTION DRUG LABEL	1
Amantadine HCL	Direct_Rx	2024-02-29	HUMAN PRESCRIPTION DRUG LABEL	4