Amantadine Hydrochloride

Product NDC: 42543-493
11-digit product format: 425430493
Labeler code: 42543
Product ID: 42543-493_20218de3-d4e9-4f7d-b1f5-bfb66e22420d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amantadine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Strides Pharma Inc.
Application: ANDA209047
Marketing category: ANDA
Marketing start: 2017-07-31
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
A209047-001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		2017-06-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209047-001	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	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	BX	2017-06-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	BX	2017-06-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	BX	2017-06-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	BX	2017-06-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	BX	2017-06-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	BX	2017-06-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	BX	2017-06-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	BX	2017-06-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	BX	2017-06-07	`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	A209047-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209047-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209047-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209047-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209047-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209047-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209047-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209047-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209047-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209047-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209047-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209047-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209047-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209047-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209047-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209047-001	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209047-001	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209047-001	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209047-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209047-001	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209047-001	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209047-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209047-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209047-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209047-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209047-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209047-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209047-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209047-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209047-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209047-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209047-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209047-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209047-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209047-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209047-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209047-001	BX	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209047-001	BX	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209047-001	BX	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209047-001	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
849389	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
e4d8f36f-d668-4728-8dca-b1c22bd9aedb	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
42543-493-01	Amantadine Hydrochloride	100 in 1 BOTTLE	CAPSULE	100		10
42543-493-05	Amantadine Hydrochloride	500 in 1 BOTTLE	CAPSULE	500		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42543-493-01	EA - Each	42543-493	73638aa7-52ca-4aac-8cff-0b52fe02096a	1	2017-08-11
42543-493-05	EA - Each	42543-493	49fa98a3-70b9-42be-95af-0da9ab329170	1	2017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42543-493	AMANTADINE HYDROCHLORIDE CAPSULE [STRIDES PHARMA INC.]	8	Current NDC, Legacy NDC, 2 package rows	20240420_e4d8f36f-d668-4728-8dca-b1c22bd9aedb.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	6326d7f5-4c7c-4541-8db1-c582f1525f60	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209047 application number: ANDA209047
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Strides Pharma Inc.	e4d8f36f-d668-4728-8dca-b1c22bd9aedb	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209047 application number: ANDA209047 ndc (product): 42543-493
Amantadine HCL	AMANTADINE HCL	Direct_Rx	f28c55c8-2754-a44d-e053-2a95a90ae798	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209047 application number: ANDA209047
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Proficient Rx LP	f0e9b795-c0a1-4c95-928c-dacaaf9b3bb5	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209047 application number: ANDA209047

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
849389	amantadine HCl 100 MG Oral Capsule	PSN	6326d7f5-4c7c-4541-8db1-c582f1525f60	103
849389	amantadine hydrochloride 100 MG Oral Capsule	SCD	6326d7f5-4c7c-4541-8db1-c582f1525f60	103
849389	amantadine HCl 100 MG Oral Capsule	PSN	e4d8f36f-d668-4728-8dca-b1c22bd9aedb	10
849389	amantadine hydrochloride 100 MG Oral Capsule	SCD	e4d8f36f-d668-4728-8dca-b1c22bd9aedb	10
849389	amantadine HCl 100 MG Oral Capsule	PSN	cdb39380-192f-480d-99a4-316f638d5cf2	5
849389	amantadine hydrochloride 100 MG Oral Capsule	SCD	cdb39380-192f-480d-99a4-316f638d5cf2	5
849389	amantadine HCl 100 MG Oral Capsule	PSN	f28c55c8-2754-a44d-e053-2a95a90ae798	4
849389	amantadine hydrochloride 100 MG Oral Capsule	SCD	f28c55c8-2754-a44d-e053-2a95a90ae798	4
849389	amantadine HCl 100 MG Oral Capsule	PSN	f0e9b795-c0a1-4c95-928c-dacaaf9b3bb5	2
849389	amantadine hydrochloride 100 MG Oral Capsule	SCD	f0e9b795-c0a1-4c95-928c-dacaaf9b3bb5	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42543-493-01	42543049301	100 CAPSULE in 1 BOTTLE (42543-493-01)	100 capsule	2017-07-31	0000-00-00	No	No	Current
42543-493-05	42543049305	500 CAPSULE in 1 BOTTLE (42543-493-05)	500 capsule	2017-07-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amantadine Hydrochloride Capsules USP Rx only	Bryant Ranch Prepack	2026-04-15	HUMAN PRESCRIPTION DRUG LABEL	103
Amantadine Hydrochloride Capsules USP Rx only	Strides Pharma Inc. \| Strides Pharma Science Limited \| Strides Alathur Private Limited	2026-01-30	HUMAN PRESCRIPTION DRUG LABEL	10
Amantadine HCL	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	4
Amantadine Hydrochloride Capsules USP Rx only	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
Amantadine Hydrochloride Capsules USP Rx only	Proficient Rx LP	2019-10-01	HUMAN PRESCRIPTION DRUG LABEL	2