Amantadine Hydrochloride

Product NDC: 68999-011
11-digit product format: 689990011
Labeler code: 68999
Product ID: 68999-011_4651addb-4284-88e1-e063-6294a90a3d13
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amantadine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Chartwell Governmental & Specialty RX, LLC.
Application: ANDA074028
Marketing category: ANDA
Marketing start: 1993-06-28
Substance: AMANTADINE HYDROCHLORIDE
Active strength: 100 mg/10mL
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 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
A074028-001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074028-001	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	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074028-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1993-06-28	`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	A074028-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074028-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074028-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074028-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074028-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074028-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074028-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074028-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074028-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074028-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074028-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074028-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074028-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074028-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074028-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074028-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074028-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074028-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074028-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074028-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074028-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074028-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074028-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074028-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074028-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074028-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074028-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074028-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074028-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074028-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074028-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074028-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074028-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074028-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074028-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074028-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074028-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074028-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074028-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074028-001	AA	1	`e64feba35796…`

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	100 mg/10mL

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
3c448cb3-7996-4a83-a9ad-23a00a431fbe	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68999-011-24	Amantadine Hydrochloride	10 in 1 TRAY	SOLUTION	10	1
68999-011-24	Amantadine Hydrochloride	2 in 1 BOX	SOLUTION	2	1
68999-011-59	Amantadine Hydrochloride	10 mL in 1 CUP, UNIT-DOSE	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
68999-011-24	ML - Milliliter	68999-011	0f2f9892-7537-49b3-a4ca-f8444295c2ef	1	2026-03-17
68999-011-59	ML - Milliliter	68999-011	98e0b2a2-7a37-4b2a-8856-588377140961	1	2026-03-17

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 Hydrochloride	AMANTADINE HYDROCHLORIDE	Chartwell Governmental & Specialty RX, LLC.	3c448cb3-7996-4a83-a9ad-23a00a431fbe	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074028 application number: ANDA074028 ndc (product): 68999-011
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Chartwell RX, LLC	52aa093c-82cc-4d81-b072-86a2b8adc9c5	2025-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074028 application number: ANDA074028

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	3c448cb3-7996-4a83-a9ad-23a00a431fbe	1
849385	amantadine hydrochloride 10 MG/ML Oral Solution	SCD	3c448cb3-7996-4a83-a9ad-23a00a431fbe	1
849385	amantadine hydrochloride 100 MG per 10 ML Oral Solution	SY	3c448cb3-7996-4a83-a9ad-23a00a431fbe	1
849385	amantadine hydrochloride 50 MG per 5 ML Oral Solution	SY	3c448cb3-7996-4a83-a9ad-23a00a431fbe	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68999-011-24	68999001124	2 TRAY in 1 BOX (68999-011-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68999-011-59)	2 tray	2025-12-17	No	No	Current
68999-011-59	68999001159	10 mL in 1 CUP, UNIT-DOSE	10 ml				Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amantadine Hydrochloride Oral Solution, USP	Chartwell Governmental & Specialty RX, LLC.	2025-12-19	HUMAN PRESCRIPTION DRUG LABEL	1