Amantadine Hydrochloride

Product NDC: 17856-0093
11-digit product format: 178560093
Labeler code: 17856
Product ID: 17856-0093_3b3e31b5-ced7-b373-e063-6294a90a16b2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMANTADINE HYDROCHLORIDE
Dosage form: SOLUTION
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA075060
Marketing category: ANDA
Marketing start: 1998-12-24
Substance: AMANTADINE HYDROCHLORIDE
Active strength: 50 mg/5mL
Pharmacologic classes: Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	17856-0093		I	Inactivated by FDA	2026-08-17
excluded package	package	17856-0093	17856-0093-1	D	Discontinued by firm	2026-08-17
excluded package	package	17856-0093	17856-0093-3	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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0093-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0093-3	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0093-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0093-3	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-0093-3	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-0093-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	17856-0093-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	17856-0093-3	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	17856-0093-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	17856-0093-3	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	17856-0093-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	17856-0093-3	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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
A075060-001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA		1998-12-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075060-001	AA

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	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA		1998-12-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA		1998-12-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA		1998-12-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA		1998-12-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA		1998-12-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA		1998-12-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA		1998-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA		1998-12-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA		1998-12-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1998-12-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1998-12-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1998-12-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1998-12-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1998-12-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1998-12-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075060-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075060-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075060-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075060-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075060-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075060-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075060-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075060-001	AA	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075060-001	AA	1	`d8e5a09893c0…`
2019-12-13 00:20 UTC	2019-12	A075060-001	AA	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A075060-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075060-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075060-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075060-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075060-001	AA	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075060-001	AA	1	`a50c72e98297…`

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, Effective, Related label table
NDC	Effective	Related label
17856-0093-1	2024-05-08	AMANTADINE HYDROCHLORIDE ORAL SOLUTION, USP 50 mg/5 mL
17856-0093-3	2024-05-08	AMANTADINE HYDROCHLORIDE ORAL SOLUTION, USP 50 mg/5 mL
17856-0093-1	2022-01-28	AMANTADINE HYDROCHLORIDE ORAL SOLUTION, USP 50 mg/5 mL
17856-0093-3	2022-01-28	AMANTADINE HYDROCHLORIDE ORAL SOLUTION, USP 50 mg/5 mL
17856-0093-1	2020-05-20	AMANTADINE HYDROCHLORIDE ORAL SOLUTION, USP 50 mg/5 mL
17856-0093-3	2020-05-20	AMANTADINE HYDROCHLORIDE ORAL SOLUTION, USP 50 mg/5 mL
17856-0093-1	2020-01-31	AMANTADINE HYDROCHLORIDE ORAL SOLUTION, USP 50 mg/5 mL
17856-0093-3	2020-01-31	AMANTADINE HYDROCHLORIDE ORAL SOLUTION, USP 50 mg/5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17856-0093-1	Amantadine Hydrochloride	72 in 1 BOX, UNIT-DOSE	SOLUTION	72	6
17856-0093-1	Amantadine Hydrochloride	10 mL in 1 CUP, UNIT-DOSE	SOLUTION	10	6
17856-0093-3	Amantadine Hydrochloride	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0093	AMANTADINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.]	5	Current NDC, Legacy NDC, 3 package rows	20240509_97d6bd4a-31ca-4b33-8353-a536835ef1e1.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amantadine	AMANTADINE	AvPAK	48c949e3-86e0-c639-e063-6294a90acdba	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075060 application number: ANDA075060
Amantadine	AMANTADINE	Xttrium Laboratories, Inc	25dd8a3c-6b11-2ea1-e063-6294a90a50cf	2025-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075060 application number: ANDA075060

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
849385	amantadine HCl 50 MG in 5 mL Oral Solution	PSN	97d6bd4a-31ca-4b33-8353-a536835ef1e1	6
849385	amantadine hydrochloride 10 MG/ML Oral Solution	SCD	97d6bd4a-31ca-4b33-8353-a536835ef1e1	6
849385	amantadine hydrochloride 100 MG per 10 ML Oral Solution	SY	97d6bd4a-31ca-4b33-8353-a536835ef1e1	6
849385	amantadine hydrochloride 50 MG per 5 ML Oral Solution	SY	97d6bd4a-31ca-4b33-8353-a536835ef1e1	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-0093-1	17856009301	72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0093-1) > 10 mL in 1 CUP, UNIT-DOSE		2020-05-20	0000-00-00	No	No	Current
17856-0093-3	17856009303	5 mL in 1 CUP, UNIT-DOSE (17856-0093-3)	5 ml	2020-05-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMANTADINE HYDROCHLORIDE ORAL SOLUTION, USP 50 mg/5 mL	ATLANTIC BIOLOGICALS CORP.	2025-07-31	HUMAN PRESCRIPTION DRUG LABEL	6