Amantadine HCl

Product NDC: 63629-2681
11-digit product format: 636292681
Labeler code: 63629
Product ID: 63629-2681_a2e36bef-667f-423e-9ef6-90989e087400
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amantadine hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078720
Marketing category: ANDA
Marketing start: 2008-11-01
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	63629-2681		I	Inactivated by FDA	2026-08-10
excluded package	package	63629-2681	63629-2681-1	I	Inactivated by FDA	2026-08-10
excluded package	package	63629-2681	63629-2681-2	I	Inactivated by FDA	2026-08-10
excluded package	package	63629-2681	63629-2681-3	I	Inactivated by FDA	2026-08-10
excluded package	package	63629-2681	63629-2681-4	I	Inactivated by FDA	2026-08-10

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	63629-2681-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-2681-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-2681-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-2681-3	`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	63629-2681-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-2681-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-2681-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-2681-3	`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	63629-2681-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-2681-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-2681-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-2681-3	`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	63629-2681-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-2681-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-2681-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-2681-3	`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	63629-2681-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-2681-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-2681-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-2681-3	`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	63629-2681-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-2681-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-2681-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-2681-3	`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	63629-2681-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-2681-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-2681-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-2681-3	`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	63629-2681-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-2681-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-2681-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-2681-3	`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	63629-2681-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-2681-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-2681-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-2681-3	`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	63629-2681-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-2681-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-2681-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-2681-3	`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	63629-2681-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-2681-4	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-2681-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-2681-3	`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	63629-2681-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-2681-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-2681-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-2681-3	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078720-001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078720-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		2008-05-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		2008-05-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		2008-05-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		2008-05-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078720-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078720-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078720-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078720-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078720-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078720-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078720-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078720-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078720-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078720-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078720-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078720-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078720-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078720-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078720-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078720-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078720-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078720-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078720-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078720-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078720-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078720-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078720-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078720-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078720-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078720-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078720-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078720-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078720-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078720-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078720-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078720-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078720-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078720-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078720-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078720-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078720-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078720-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078720-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078720-001	AB	1	`cb3db0bc1861…`

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
63629-2681-1	AMANTADINE HCL
63629-2681-2	AMANTADINE HCL
63629-2681-3	AMANTADINE HCL
63629-2681-4	AMANTADINE HCL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-2681-1	Amantadine HCl	20 in 1 BOTTLE	CAPSULE	20	3
63629-2681-2	Amantadine HCl	30 in 1 BOTTLE	CAPSULE	30	3
63629-2681-3	Amantadine HCl	10 in 1 BOTTLE	CAPSULE	10	3
63629-2681-4	Amantadine HCl	14 in 1 BOTTLE	CAPSULE	14	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2681-1	EA - Each	63629-2681	7843840d-f3b6-4e6f-885c-d0b84ffa3ddc	1	2012-07-24
63629-2681-2	EA - Each	63629-2681	3bcda13f-77b6-413d-a6fb-2595b84166ff	1	2012-07-24
63629-2681-3	EA - Each	63629-2681	eecf2d8c-0c56-4e81-86a9-a272cc1849c4	1	2012-07-24
63629-2681-4	EA - Each	63629-2681	684344c9-55a1-474b-8669-35fa715a93eb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMANTADINE HYDROCHLORIDE	ACTIVE INGREDIENT	M6Q1EO9TD0	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3
AMANTADINE	ACTIVE MOIETY	BF4C9Z1J53	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3
SORBITAN	INACTIVE INGREDIENT	6O92ICV9RU	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3
SOYBEAN OIL	INACTIVE INGREDIENT	241ATL177A	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2681	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3	Legacy NDC, 4 package rows	20121016_a2caed21-e9a3-228e-70a8-de30a1b368be.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amantadine HCl	AMANTADINE HYDROCHLORIDE	AvPAK	461e6444-189e-62ed-6c61-1c36a04459c6	2025-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078720 application number: ANDA078720
Amantadine HCl	AMANTADINE HYDROCHLORIDE	AvKARE	bfd129ae-8b0a-f118-b7d0-45d106290b63	2025-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078720 application number: ANDA078720
Amantadine HCl	AMANTADINE HYDROCHLORIDE	Bionpharma Inc.	d6ca4d20-72c5-496c-9ac7-1f5cb407a742	2025-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078720 application number: ANDA078720

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	a2caed21-e9a3-228e-70a8-de30a1b368be	3
849389	amantadine hydrochloride 100 MG Oral Capsule	SCD	a2caed21-e9a3-228e-70a8-de30a1b368be	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
63629-2681-1	63629268101	20 in 1 BOTTLE	Historical
63629-2681-2	63629268102	30 in 1 BOTTLE	Historical
63629-2681-3	63629268103	10 in 1 BOTTLE	Historical
63629-2681-4	63629268104	14 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMANTADINE HCL	Bryant Ranch Prepack \| Banner Pharmacaps Inc.	2012-10-12	HUMAN PRESCRIPTION DRUG LABEL	3