AMANTADINE HYDROCHLORIDE

Product NDC: 24689-112
Requested package NDC: 24689-112-02
11-digit product format: 246890112
Labeler code: 24689
Product ID: 24689-112_d446abf8-c0db-f07f-e053-2995a90a353c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amantadine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Apnar Pharma LP
Application: ANDA210215
Marketing category: ANDA
Marketing start: 2022-01-20
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: 2023-12-31
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	24689-112	24689-112-02	I	Inactivated by FDA		2026-08-17

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
A210215-001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2020-03-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210215-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210215-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-03-10	`a50c72e98297…`

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	A210215-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210215-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210215-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210215-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210215-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210215-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210215-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210215-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210215-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210215-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210215-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210215-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210215-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210215-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210215-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210215-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210215-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210215-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210215-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210215-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210215-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210215-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210215-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210215-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210215-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210215-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210215-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210215-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210215-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210215-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210215-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210215-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210215-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210215-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210215-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210215-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210215-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210215-001	AB	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
24689-112-01	AMANTADINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET	100		2
24689-112-02	AMANTADINE HYDROCHLORIDE	500 in 1 BOTTLE	TABLET	500		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24689-112	AMANTADINE HYDROCHLORIDE TABLET [APNAR PHARMA LP]	2	Legacy NDC, 2 package rows	20240601_d446abf8-c0da-f07f-e053-2995a90a353c.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Marlex Pharmaceuticals Inc	25af52ee-9b29-4c07-a383-62d4537b63e0	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210215 application number: ANDA210215

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
849395	amantadine HCl 100 MG Oral Tablet	PSN	d446abf8-c0da-f07f-e053-2995a90a353c	2
849395	amantadine hydrochloride 100 MG Oral Tablet	SCD	d446abf8-c0da-f07f-e053-2995a90a353c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
24689-112-02	24689011202	500 TABLET in 1 BOTTLE (24689-112-02)	500 tablet	2022-01-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMANTADINE HYDROCHLORIDE- amantadine hydrochloride tablet	Apnar Pharma LP \| InvaTech Pharma Solutions LLC	2024-03-09	HUMAN PRESCRIPTION DRUG LABEL	2