amantadine hydrochloride

Product NDC: 67046-1508
11-digit product format: 670461508
Labeler code: 67046
Product ID: 67046-1508_2cb6e7e3-9e71-6a9c-e063-6394a90ab7c0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amantadine hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Coupler LLC
Application: ANDA208278
Marketing category: ANDA
Marketing start: 2025-01-27
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: 2026-12-31
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
A208278-001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		2016-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208278-001	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	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`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	A208278-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208278-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208278-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208278-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208278-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208278-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208278-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208278-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208278-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208278-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208278-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208278-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208278-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208278-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208278-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208278-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208278-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208278-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208278-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208278-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208278-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208278-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208278-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208278-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208278-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208278-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208278-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208278-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208278-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208278-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208278-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208278-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208278-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208278-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208278-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208278-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208278-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208278-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208278-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208278-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: amantadine hydrochloride
Listing expiration: 2026-12-31

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
2cb6e83d-e635-b150-e063-6294a90ad61d	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
67046-1508-3	amantadine hydrochloride	30 in 1 BLISTER PACK	CAPSULE	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-1508	AMANTADINE HYDROCHLORIDE CAPSULE [COUPLER LLC]	1	Current NDC, 1 package rows	20250129_2cb6e83d-e635-b150-e063-6294a90ad61d.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	AvKARE	547904f3-84a3-1ccb-e063-6294a90a6fb6	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208278 application number: ANDA208278
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	8e578f11-6112-4a1f-8de4-a76870bb62c7	2025-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208278 application number: ANDA208278
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	609dc911-1e9d-4ebd-b64b-f44054e5582e	2025-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208278 application number: ANDA208278
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	Zydus Lifesciences Limited	579e6c23-6286-4b80-88de-c86c0e5cc2b2	2025-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208278 application number: ANDA208278
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	Coupler LLC	2cb6e83d-e635-b150-e063-6294a90ad61d	2025-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208278 application number: ANDA208278 ndc (product): 67046-1508
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	Proficient Rx LP	743d1b73-f47e-4bbf-bb52-45b1e7f17308	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208278 application number: ANDA208278

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	2cb6e83d-e635-b150-e063-6294a90ad61d	1
849389	amantadine hydrochloride 100 MG Oral Capsule	SCD	2cb6e83d-e635-b150-e063-6294a90ad61d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1508-3	67046150803	30 CAPSULE in 1 BLISTER PACK (67046-1508-3)	30 capsule	2025-01-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amantadine Hydrochloride Capsules, USP Rx only	Coupler LLC \| Zydus Pharmaceuticals (USA) Inc.	2025-01-27	HUMAN PRESCRIPTION DRUG LABEL	1