Amantadine HCl

Product NDC: 69387-100
11-digit product format: 693870100
Labeler code: 69387
Product ID: 69387-100_ac286359-2ef9-44c7-aa7d-6ed9120debfe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMANTADINE HYDROCHLORIDE
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Banner Life Sciences LLC.
Application: ANDA078720
Marketing category: ANDA
Marketing start: 2015-09-07
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: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69387-100		I	Inactivated by FDA	2026-08-10
excluded package	package	69387-100	69387-100-01	I	Inactivated by FDA	2026-08-10
excluded package	package	69387-100	69387-100-05	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 · 66 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	69387-100-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69387-100-05	`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	69387-100-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69387-100-05	`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	69387-100-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69387-100-05	`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	69387-100-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69387-100-05	`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	69387-100-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69387-100-05	`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	69387-100-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69387-100-05	`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	69387-100-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69387-100-05	`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	69387-100-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69387-100-05	`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	69387-100-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69387-100-05	`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	69387-100-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69387-100-05	`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	69387-100-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69387-100-05	`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	69387-100-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69387-100-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69387-100-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69387-100-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69387-100-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69387-100-05	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69387-100-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69387-100-05	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69387-100-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69387-100-05	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69387-100-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69387-100-05	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69387-100-01	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69387-100-05	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69387-100-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69387-100-05	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69387-100-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69387-100-05	`e2bbac7714bc…`	`27bdfed8d636…`

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69387-100-01	2020-01-31	C162847	48780-1	9d75b9cf-f566-f424-e053-dadaa90a57ce	Amantadine Hydrochloride Capsules, USP Rx only
69387-100-05	2020-01-31	C162847	48780-1	9d75b9cf-f566-f424-e053-dadaa90a57ce	Amantadine Hydrochloride Capsules, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69387-100-01	Amantadine HCl	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100		2
69387-100-05	Amantadine HCl	500 in 1 BOTTLE	CAPSULE, LIQUID FILLED	500		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69387-100-01	EA - Each	69387-100	73e25319-c154-4cdd-a286-f4a6e4c561ec	1	2015-10-02
69387-100-05	EA - Each	69387-100	db1be7a9-a946-4b89-a292-663117f50f80	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMANTADINE HYDROCHLORIDE	ACTIVE INGREDIENT	M6Q1EO9TD0	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.]	2
AMANTADINE	ACTIVE MOIETY	BF4C9Z1J53	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.]	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.]	2
SORBITAN	INACTIVE INGREDIENT	6O92ICV9RU	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.]	2
SOYBEAN OIL	INACTIVE INGREDIENT	241ATL177A	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.]	2
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69387-100	AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.]	2	Legacy NDC, 2 package rows	20150911_d6e6e111-38da-43a2-b6c4-15e69b720495.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	d6e6e111-38da-43a2-b6c4-15e69b720495	2
849389	amantadine hydrochloride 100 MG Oral Capsule	SCD	d6e6e111-38da-43a2-b6c4-15e69b720495	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
69387-100-01	69387010001	100 in 1 BOTTLE	Historical
69387-100-05	69387010005	500 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amantadine Hydrochloride Capsules, USP Rx only	Banner Life Sciences LLC. \| Banner Pharmacaps Inc	2015-09-08	Human Prescription Drug Label	2