Amantadine

Product NDC: 0116-4010
11-digit product format: 001164010
Labeler code: 0116
Product ID: 0116-4010_3479947d-22a8-67e8-e063-6294a90ae41c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amantadine
Dosage form: SOLUTION
Route: ORAL
Labeler: Xttrium Laboratories, Inc
Application: ANDA075060
Marketing category: ANDA
Marketing start: 2024-11-05
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: 2027-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Amantadine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMANTADINE HYDROCHLORIDE	50 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
M6Q1EO9TD0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
849385	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
25dd8a3c-6b11-2ea1-e063-6294a90a50cf	Available on FDA.report

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
b7b57a62-2f7f-1a22-2cb2-eaa5c08d4721	Product name	2	20220224
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
14e11aaf-885f-472f-a02a-c6a3f28df907	Product name	1	20180515
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
82f46845-b4c7-48da-a389-ba5721b956c9	Product name	1	20171103
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0116-4010-10	Amantadine	10 mL in 1 CUP, UNIT-DOSE	SOLUTION	10	2
0116-4010-16	Amantadine	473 mL in 1 BOTTLE	SOLUTION	473	2
0116-4010-41	Amantadine	10 in 1 TRAY	SOLUTION	10	2
0116-4010-41	Amantadine	100 in 1 CASE	SOLUTION	100	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0116-4010-10	ML - Milliliter	0116-4010	4f6689fa-38ad-41f0-b0e7-42a20aed1504	1	2025-07-08
0116-4010-16	ML - Milliliter	0116-4010	5125b5ac-bbac-402e-8ed3-8d718552ef1b	1	2025-02-10
0116-4010-41	ML - Milliliter	0116-4010	f520c126-fec1-4545-b0af-29db845b4cb4	1	2025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0116-4010	AMANTADINE SOLUTION [XTTRIUM LABORATORIES, INC]	1	Current NDC, 4 package rows	20241106_25dd8a3c-6b11-2ea1-e063-6294a90a50cf.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 ndc (product): 0116-4010

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M6Q1EO9TD0	AMANTADINE HYDROCHLORIDE	665-66-7	AMANTADINE HYDROCHLORIDE
BF4C9Z1J53	AMANTADINE	768-94-5	Amantadine

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	25dd8a3c-6b11-2ea1-e063-6294a90a50cf	2
849385	amantadine hydrochloride 10 MG/ML Oral Solution	SCD	25dd8a3c-6b11-2ea1-e063-6294a90a50cf	2
849385	amantadine hydrochloride 100 MG per 10 ML Oral Solution	SY	25dd8a3c-6b11-2ea1-e063-6294a90a50cf	2
849385	amantadine hydrochloride 50 MG per 5 ML Oral Solution	SY	25dd8a3c-6b11-2ea1-e063-6294a90a50cf	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0116-4010-10	00116401010	10 mL in 1 CUP, UNIT-DOSE	10 ml				Historical
0116-4010-16	00116401016	473 mL in 1 BOTTLE (0116-4010-16)	473 ml	2024-11-05	No	No	Current
0116-4010-41	00116401041	100 TRAY in 1 CASE (0116-4010-41) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4010-10)	100 tray	2024-11-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amantadine 16oz, 10mL Lid, Insert	Xttrium Laboratories, Inc \| Xttrium Laboratories, Inc.	2025-05-21	HUMAN PRESCRIPTION DRUG LABEL	2