Amantadine Hydrochloride

Product NDC: 60687-797
Requested package NDC: 60687-797-56
11-digit product format: 606870797
Labeler code: 60687
Product ID: 60687-797_11e80915-df52-1580-e063-6394a90a67b1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amantadine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: American Health Packaging
Application: ANDA074509
Marketing category: ANDA
Marketing start: 2024-02-26
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A074509-001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074509-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A074509-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074509-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074509-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074509-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074509-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074509-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074509-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074509-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074509-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074509-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074509-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074509-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074509-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074509-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074509-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074509-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074509-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074509-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074509-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074509-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074509-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074509-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074509-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074509-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074509-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074509-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074509-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074509-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074509-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074509-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074509-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074509-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074509-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074509-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074509-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074509-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074509-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074509-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074509-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074509-001	AA	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Amantadine Hydrochloride
Listing expiration: 2026-12-31

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
5a8f16cc-e5d5-4097-8297-10c8166c7a0e	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60687-797-42	Amantadine Hydrochloride	10 mL in 1 CUP, UNIT-DOSE	SOLUTION	10	1
60687-797-48	Amantadine Hydrochloride	10 in 1 TRAY	SOLUTION	10	1
60687-797-56	Amantadine Hydrochloride	10 in 1 CASE	SOLUTION	10	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-797-42	ML - Milliliter	60687-797	a3026f15-0ef2-4ae0-a6d6-7a9af732b198	1	2024-05-16
60687-797-56	ML - Milliliter	60687-797	2dd93659-3dbb-4c35-ace6-4438c023534a	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-797	AMANTADINE HYDROCHLORIDE SOLUTION [AMERICAN HEALTH PACKAGING]	1	Current NDC, 3 package rows	20240226_5a8f16cc-e5d5-4097-8297-10c8166c7a0e.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	Cardinal Health 107, LLC	5989098d-2855-4b5f-9a06-64a83656c078	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074509 application number: ANDA074509
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	be411327-5ac7-46df-b5e4-32a11b419b15	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074509 application number: ANDA074509
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	6311b46b-23cc-40c1-93c2-f7c92606386f	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074509 application number: ANDA074509
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	American Health Packaging	5a8f16cc-e5d5-4097-8297-10c8166c7a0e	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074509 application number: ANDA074509 ndc (package): 60687-797-56 ndc (product): 60687-797 ndc11 (package): 60687079756

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	5a8f16cc-e5d5-4097-8297-10c8166c7a0e	1
849385	amantadine hydrochloride 10 MG/ML Oral Solution	SCD	5a8f16cc-e5d5-4097-8297-10c8166c7a0e	1
849385	amantadine hydrochloride 100 MG per 10 ML Oral Solution	SY	5a8f16cc-e5d5-4097-8297-10c8166c7a0e	1
849385	amantadine hydrochloride 50 MG per 5 ML Oral Solution	SY	5a8f16cc-e5d5-4097-8297-10c8166c7a0e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60687-797-56	60687079756	10 TRAY in 1 CASE (60687-797-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-797-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-797-42)	10 tray	2024-02-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amantadine Hydrochloride Oral Solution USP I0646C0124 R01/24 Rx only	American Health Packaging	2024-02-21	HUMAN PRESCRIPTION DRUG LABEL	1