Amantadine Hydrochloride

Product NDC: 33261-773
11-digit product format: 332610773
Labeler code: 33261
Product ID: 33261-773_1a42734f-af17-498b-bc15-a3f7e0004fae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amantadine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA071293
Marketing category: ANDA
Marketing start: 1987-02-18
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	33261-773		I	Inactivated by FDA	2026-08-17
excluded package	package	33261-773	33261-773-10	I	Inactivated by FDA	2026-08-17
excluded package	package	33261-773	33261-773-30	I	Inactivated by FDA	2026-08-17
excluded package	package	33261-773	33261-773-60	I	Inactivated by FDA	2026-08-17
excluded package	package	33261-773	33261-773-90	I	Inactivated by FDA	2026-08-17

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 2 · 105 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	33261-773-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-773-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-773-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-773-10	`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	33261-773-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-773-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-773-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-773-10	`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	33261-773-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-773-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-773-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-773-10	`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	33261-773-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-773-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-773-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-773-10	`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	33261-773-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-773-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-773-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-773-10	`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	33261-773-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-773-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-773-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-773-10	`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	33261-773-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-773-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-773-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-773-10	`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	33261-773-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-773-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-773-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-773-10	`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	33261-773-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-773-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-773-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-773-10	`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	33261-773-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-773-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-773-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-773-10	`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	33261-773-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33261-773-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33261-773-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33261-773-10	`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	33261-773-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33261-773-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33261-773-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33261-773-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A071293-001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071293-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	1987-02-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	1987-02-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	1987-02-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	1987-02-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`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	A071293-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071293-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071293-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071293-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071293-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071293-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071293-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071293-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071293-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071293-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071293-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071293-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071293-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071293-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071293-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071293-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071293-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071293-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071293-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071293-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071293-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071293-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071293-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071293-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071293-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071293-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071293-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071293-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071293-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071293-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071293-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071293-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071293-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071293-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071293-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071293-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071293-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071293-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071293-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071293-001	AB	1	`e64feba35796…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
33261-773-10	Amantadine Hydrochloride Capsules, USP
33261-773-30	Amantadine Hydrochloride Capsules, USP
33261-773-60	Amantadine Hydrochloride Capsules, USP
33261-773-90	Amantadine Hydrochloride Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
33261-773-10	Amantadine Hydrochloride	10 in 1 BOTTLE, PLASTIC	CAPSULE	10	1
33261-773-30	Amantadine Hydrochloride	30 in 1 BOTTLE, PLASTIC	CAPSULE	30	1
33261-773-60	Amantadine Hydrochloride	60 in 1 BOTTLE, PLASTIC	CAPSULE	60	1
33261-773-90	Amantadine Hydrochloride	90 in 1 BOTTLE, PLASTIC	CAPSULE	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33261-773-10	EA - Each	33261-773	db4abbaa-0247-45f6-8d9a-085fceff6af8	1	2015-10-02
33261-773-30	EA - Each	33261-773	49757fcf-fe2a-4741-9cb4-325aae8bc7b2	1	2015-10-02
33261-773-60	EA - Each	33261-773	ce183fc3-994e-4f16-abf3-ec54ccfeb77b	1	2015-10-02
33261-773-90	EA - Each	33261-773	02806a09-2813-4aac-9d43-bc830d51a0ca	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMANTADINE HYDROCHLORIDE	ACTIVE INGREDIENT	M6Q1EO9TD0	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
AMANTADINE	ACTIVE MOIETY	BF4C9Z1J53	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
ETHYLCELLULOSE (7 MPA.S)	INACTIVE INGREDIENT	H3UP11403C	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-773	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 4 package rows	20131204_0637f133-1f9d-48b3-b82f-a4e16f926cd6.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	A-S Medication Solutions	da693bb0-0cc8-485d-89a7-c8cf28d440f3	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071293 application number: ANDA071293

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	0637f133-1f9d-48b3-b82f-a4e16f926cd6	1
849389	amantadine hydrochloride 100 MG Oral Capsule	SCD	0637f133-1f9d-48b3-b82f-a4e16f926cd6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33261-773-10	33261077310	10 in 1 BOTTLE, PLASTIC	Historical
33261-773-30	33261077330	30 in 1 BOTTLE, PLASTIC	Historical
33261-773-60	33261077360	60 in 1 BOTTLE, PLASTIC	Historical
33261-773-90	33261077390	90 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amantadine Hydrochloride Capsules, USP	Aidarex Pharmaceuticals LLC	2013-11-15	HUMAN PRESCRIPTION DRUG LABEL	1