Amantadine Hydrochloride

Product NDC: 0781-2320
Requested package NDC: 0781-2320-01
11-digit product format: 007812320
Labeler code: 0781
Product ID: 0781-2320_4c656ec7-6bab-4946-a0a2-8061f2913d36
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amantadine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Sandoz Inc.
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: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0781-2320	0781-2320-01	D	Discontinued by firm		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 1 · 12 matching rows.

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

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

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMANTADINE HYDROCHLORIDE	ACTIVE INGREDIENT	M6Q1EO9TD0	AMANTADINE HYDROCHLORIDE CAPSULE [SANDOZ INC]	12
AMANTADINE	ACTIVE MOIETY	BF4C9Z1J53	AMANTADINE HYDROCHLORIDE CAPSULE [SANDOZ INC]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMANTADINE HYDROCHLORIDE CAPSULE [SANDOZ INC]	12
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AMANTADINE HYDROCHLORIDE CAPSULE [SANDOZ INC]	12
ETHYLCELLULOSE (7 MPA.S)	INACTIVE INGREDIENT	H3UP11403C	AMANTADINE HYDROCHLORIDE CAPSULE [SANDOZ INC]	12
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMANTADINE HYDROCHLORIDE CAPSULE [SANDOZ INC]	12
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMANTADINE HYDROCHLORIDE CAPSULE [SANDOZ INC]	12
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMANTADINE HYDROCHLORIDE CAPSULE [SANDOZ INC]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMANTADINE HYDROCHLORIDE CAPSULE [SANDOZ INC]	12
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	AMANTADINE HYDROCHLORIDE CAPSULE [SANDOZ INC]	12
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	AMANTADINE HYDROCHLORIDE CAPSULE [SANDOZ INC]	12
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMANTADINE HYDROCHLORIDE CAPSULE [SANDOZ INC]	12
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMANTADINE HYDROCHLORIDE CAPSULE [SANDOZ INC]	12
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMANTADINE HYDROCHLORIDE CAPSULE [SANDOZ INC]	12

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-2320-01	00781232001	100 CAPSULE in 1 BOTTLE (0781-2320-01)	100 capsule	1987-02-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amantadine Hydrochloride Capsules, USP Rx Only	Sandoz Inc.	2020-01-27	HUMAN PRESCRIPTION DRUG LABEL	17