amantadine hydrochloride

Product NDC: 42806-716
11-digit product format: 428060716
Labeler code: 42806
Product ID: 42806-716_1497ce1d-a997-4828-a08d-3f93653a88d5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amantadine hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: EPIC PHARMA LLC
Application: ANDA214580
Marketing category: ANDA
Marketing start: 2021-06-17
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
A214580-001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		2022-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214580-001	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	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214580-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2022-12-20	`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	A214580-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214580-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214580-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214580-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214580-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214580-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214580-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214580-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214580-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214580-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214580-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214580-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214580-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214580-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214580-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214580-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214580-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214580-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214580-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214580-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214580-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214580-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214580-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214580-001	AB	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214580-001	AB	1	`a50c72e98297…`

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
0f70c79a-92a4-4a38-bbdd-900adc4c2e93	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
b7b57a62-2f7f-1a22-2cb2-eaa5c08d4721	Product name	2	20220224
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
14e11aaf-885f-472f-a02a-c6a3f28df907	Product name	1	20180515
82f46845-b4c7-48da-a389-ba5721b956c9	Product name	1	20171103
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42806-716-05	amantadine hydrochloride	500 in 1 BOTTLE	CAPSULE	500		8
42806-716-11	amantadine hydrochloride	10 in 1 BOTTLE	CAPSULE	10		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42806-716	AMANTADINE HYDROCHLORIDE CAPSULE [EPIC PHARMA LLC]	7	Current NDC, Legacy NDC, 2 package rows	20250510_0f70c79a-92a4-4a38-bbdd-900adc4c2e93.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
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	EPIC PHARMA LLC	0f70c79a-92a4-4a38-bbdd-900adc4c2e93	2025-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214580 application number: ANDA214580 ndc (product): 42806-716

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	0f70c79a-92a4-4a38-bbdd-900adc4c2e93	8
849389	amantadine hydrochloride 100 MG Oral Capsule	SCD	0f70c79a-92a4-4a38-bbdd-900adc4c2e93	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42806-716-05	42806071605	500 CAPSULE in 1 BOTTLE (42806-716-05)	500 capsule	2021-06-17	0000-00-00	No	No	Current
42806-716-10	42806071610	10 CAPSULE in 1 BOTTLE (42806-716-10)	10 capsule	2022-12-30	0000-00-00	No	No	Current
42806-716-11	42806071611	10 CAPSULE in 1 BOTTLE (42806-716-11)	10 capsule	2021-06-17		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amantadine Hydrochloride Capsules, USP	EPIC PHARMA LLC \| Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd	2025-06-06	HUMAN PRESCRIPTION DRUG LABEL	8