Amantadine Hydrochloride

Product NDC: 55289-012
11-digit product format: 552890012
Labeler code: 55289
Product ID: 55289-012_7bad8ad7-3a13-4a5b-e053-2991aa0aee05
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amantadine hydrochloride
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA070589
Marketing category: ANDA
Marketing start: 2011-09-15
Marketing end: 0000-00-00
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: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55289-012		D	Discontinued by firm	2026-10-16
excluded package	package	55289-012	55289-012-10	D	Discontinued by firm	2026-10-16
excluded package	package	55289-012	55289-012-14	D	Discontinued by firm	2026-10-16
excluded package	package	55289-012	55289-012-20	D	Discontinued by firm	2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55289-012-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55289-012-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55289-012-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55289-012-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55289-012-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55289-012-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55289-012-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55289-012-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55289-012-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55289-012-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55289-012-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55289-012-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55289-012-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55289-012-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55289-012-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55289-012-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55289-012-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55289-012-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55289-012-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55289-012-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55289-012-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55289-012-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55289-012-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55289-012-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55289-012-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55289-012-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55289-012-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55289-012-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55289-012-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55289-012-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55289-012-14	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55289-012-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55289-012-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55289-012-14	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55289-012-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55289-012-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A070589-001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1986-08-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070589-001	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 · 44 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
2026-10-15 13:18:30	2026-09	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070589-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	1986-08-05	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A070589-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070589-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070589-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A070589-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55289-012-10	EA - Each	55289-012	a697aff8-f407-42e8-8a1f-18c57bfbd18e	1	2012-07-24
55289-012-14	EA - Each	55289-012	b6c66fb0-781d-43cc-abe2-a304cb455d90	1	2012-07-24
55289-012-20	EA - Each	55289-012	a86fb008-b690-43f0-84c2-5e6f0e749c0f	1	2012-07-24

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	Upsher-Smith Laboratories, LLC	5232b933-1df9-43b4-8ac2-61bfa4855e68	2025-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070589 application number: ANDA070589