Rimantadine Hydrochloride

Product NDC: 0115-1911
Requested package NDC: 0115-1911-01
11-digit product format: 001151911
Labeler code: 0115
Product ID: 0115-1911_b5f5cd6c-3874-4507-bbd4-72e8c5bfe17f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rimantadine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA076132
Marketing category: ANDA
Marketing start: 2021-11-16
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: 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
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.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RIMANTADINE HYDROCHLORIDE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JEI07OOS8Y	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
856605	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
49f7d69a-820b-4c75-a31d-b2104c019c12	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508
e3741a5c-ae1e-d22a-b07b-61424fa8cd54	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0115-1911-01	Rimantadine Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100		10
0115-1911-02	Rimantadine Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-1911-01	EA - Each	0115-1911	8c31417b-a4d4-40d9-bc79-a473234ed06f	1	2012-07-24

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
ARGININE	ACTIVE INGREDIENT	94ZLA3W45F	RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
RIMANTADINE HYDROCHLORIDE	ACTIVE INGREDIENT	JEI07OOS8Y	RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
ARGININE	ACTIVE MOIETY	94ZLA3W45F	RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
RIMANTADINE	ACTIVE MOIETY	0T2EF4JQTU	RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
Rimantadine Hydrochloride	ACTIVE INGREDIENT	JEI07OOS8Y	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	3
Rimantadine	ACTIVE MOIETY	0T2EF4JQTU	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	3
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	3
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	3
Rimantadine Hydrochloride	ACTIVE INGREDIENT	JEI07OOS8Y	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
Rimantadine	ACTIVE MOIETY	0T2EF4JQTU	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
Rimantadine Hydrochloride	ACTIVE INGREDIENT	JEI07OOS8Y	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
Rimantadine Hydrochloride	ACTIVE INGREDIENT	JEI07OOS8Y	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
Rimantadine	ACTIVE MOIETY	0T2EF4JQTU	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
Rimantadine	ACTIVE MOIETY	0T2EF4JQTU	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0115-1911	RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	10	Current NDC, Legacy NDC, 2 package rows	20240101_49f7d69a-820b-4c75-a31d-b2104c019c12.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
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 ndc (package): 0115-1911-01 ndc (product): 0115-1911 ndc11 (package): 00115191101

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
856605	riMANTAdine HCl 100 MG Oral Tablet	PSN	49f7d69a-820b-4c75-a31d-b2104c019c12	10
856605	rimantadine hydrochloride 100 MG Oral Tablet	SCD	49f7d69a-820b-4c75-a31d-b2104c019c12	10
856605	riMANTAdine HCl 100 MG Oral Tablet	PSN	870089d6-87e4-46b9-bcfb-c5b82cf06c3f	8
856605	rimantadine hydrochloride 100 MG Oral Tablet	SCD	870089d6-87e4-46b9-bcfb-c5b82cf06c3f	8
856605	riMANTAdine HCl 100 MG Oral Tablet	PSN	a1d00c0f-ec9d-4849-b3b5-9c0dff07026c	2
856605	rimantadine hydrochloride 100 MG Oral Tablet	SCD	a1d00c0f-ec9d-4849-b3b5-9c0dff07026c	2
856605	riMANTAdine HCl 100 MG Oral Tablet	PSN	08d7b0df-a353-49a0-92ac-64028d4084b7	1
856605	riMANTAdine HCl 100 MG Oral Tablet	PSN	48842cd7-2d78-455a-a688-b148347b6dd5	1
856605	rimantadine hydrochloride 100 MG Oral Tablet	SCD	08d7b0df-a353-49a0-92ac-64028d4084b7	1
856605	rimantadine hydrochloride 100 MG Oral Tablet	SCD	48842cd7-2d78-455a-a688-b148347b6dd5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0115-1911-01	00115191101	100 TABLET, FILM COATED in 1 BOTTLE (0115-1911-01)	2021-11-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rimantadine Hydrochloride Tablets, USP (100 mg) Rx Only	Amneal Pharmaceuticals of New York LLC \| Amneal Pharmaceuticals Private Limited	2023-12-31	HUMAN PRESCRIPTION DRUG LABEL	10
Rimantadine Hydrochloride Tablets (100 mg) Rx only	Bryant Ranch Prepack	2019-09-12	HUMAN PRESCRIPTION DRUG LABEL	1002
RIMANTADINE HYDROCHLORIDE TABLETS, 100 MG	STAT Rx USA LLC \| PSS World Medical Inc.	2012-08-14	HUMAN PRESCRIPTION DRUG LABEL	1
RIMANTADINE HYDROCHLORIDE TABLETS, 100 MG	H.J. Harkins Company, Inc. \| Impax Laboratories Inc \| Global Pharmaceuticals, Division of Impax Laboratories Inc. \| Impax Laboratories Taiwan Inc.	2011-09-12	HUMAN PRESCRIPTION DRUG LABEL	1
Rimantalist	Physician Therapeutics LLC \| Impax Laboratories Taiwan Inc. \| H.J. Harkins Company, Inc. \| Targeted Medical Pharma, Inc.	2011-08-01	HUMAN PRESCRIPTION DRUG LABEL	8
RIMANTADINE HYDROCHLORIDE TABLETS, 100 MG	Carilion Materials Management	2010-05-17	HUMAN PRESCRIPTION DRUG LABEL	2