Rimantadine Hydrochloride

Product NDC: 63629-3552
11-digit product format: 636293552
Labeler code: 63629
Product ID: 63629-3552_8c59d87f-dab5-486f-8802-a343241cf41d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rimantadine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA076132
Marketing category: ANDA
Marketing start: 2005-04-01
Marketing end: 0000-00-00
Substance: RIMANTADINE 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: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-3552		D	Discontinued by firm	2026-10-05
excluded package	package	63629-3552	63629-3552-1	D	Discontinued by firm	2026-10-05
excluded package	package	63629-3552	63629-3552-2	D	Discontinued by firm	2026-10-05

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3552-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3552-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3552-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3552-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3552-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3552-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3552-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3552-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3552-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3552-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3552-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3552-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3552-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3552-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3552-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3552-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3552-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3552-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3552-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3552-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-3552-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-3552-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-3552-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-3552-2	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A076132-001	RIMANTADINE HYDROCHLORIDE	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		RS	2002-08-30

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	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		RS	2002-08-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		RS	2002-08-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		RS	2002-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		RS	2002-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		RS	2002-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		RS	2002-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		RS	2002-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		RS	2002-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		RS	2002-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		RS	2002-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		RS	2002-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		RS	2002-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		RS	2002-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		RS	2002-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		RS	2002-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		RS	2002-08-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-08-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-08-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-08-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-08-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-08-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-08-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-08-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-08-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-08-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-08-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-08-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-08-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-08-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		RS	2002-08-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		RS	2002-08-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		RS	2002-08-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-08-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-08-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-08-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-08-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-08-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-08-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-08-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076132-001	RIMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-08-30	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076132-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076132-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076132-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076132-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076132-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076132-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076132-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076132-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076132-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076132-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076132-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076132-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076132-001	AB	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076132-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076132-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076132-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076132-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076132-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076132-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076132-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076132-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076132-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076132-001	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-3552-1	EA - Each	63629-3552	37c827d8-5249-4525-a104-49d62bb7359a	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RIMANTADINE HYDROCHLORIDE	ACTIVE INGREDIENT	JEI07OOS8Y	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
RIMANTADINE	ACTIVE MOIETY	0T2EF4JQTU	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000

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
Rimantadine Hydrochloride	RIMANTADINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	49f7d69a-820b-4c75-a31d-b2104c019c12	2023-12-31	Adverse reactions	Exact identifier application applno (ANDA): 076132 application number: ANDA076132

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JEI07OOS8Y	RIMANTADINE HYDROCHLORIDE	1501-84-4	RIMANTADINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-3552-1	63629355201	30 TABLET, FILM COATED in 1 BOTTLE (63629-3552-1)	2009-11-20	0000-00-00	No	No	Current
63629-3552-2	63629355202	10 TABLET, FILM COATED in 1 BOTTLE (63629-3552-2)	2009-11-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rimantadine Hydrochloride Tablets (100 mg) Rx only	Bryant Ranch Prepack	2019-09-12	HUMAN PRESCRIPTION DRUG LABEL	1002