GOCOVRI

Product NDC: 70482-085
11-digit product format: 704820085
Labeler code: 70482
Product ID: 70482-085_41c15d67-44b5-5c87-e063-6294a90adcc8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMANTADINE
Dosage form: CAPSULE, COATED PELLETS
Route: ORAL
Labeler: Adamas Pharma, LLC
Application: NDA208944
Marketing category: NDA
Marketing start: 2017-08-24
Substance: AMANTADINE
Active strength: 68.5 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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208944-001	GOCOVRI	AMANTADINE HYDROCHLORIDE	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24
N208944-002	GOCOVRI	AMANTADINE HYDROCHLORIDE	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24

Orange Book patents#

Current patent rows page 1 of 1 · 34 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208944-001	8389578	2028-01-22	U-2105		2017-09-21
N208944-001	11197835	2030-12-02	U-2106		2022-01-12
N208944-001	8741343	2030-12-02	U-2106		2017-09-21
N208944-001	9867791	2030-12-02	U-2106		2018-01-16
N208944-001	9867792	2030-12-02	U-2106		2018-01-16
N208944-001	9867793	2030-12-02	U-2106		2018-01-16
N208944-001	9877933	2030-12-02	U-2224		2018-01-30
N208944-001	10646456	2034-06-17	U-2808		2020-07-14
N208944-001	11903908	2034-06-17	U-3822		2024-03-08
N208944-001	10154971	2034-12-04	U-2459		2018-12-18
N208944-001	11065213	2038-08-23		Drug product	2021-07-20
N208944-001	11077073	2038-08-23	U-2106		2021-08-04
N208944-001	11077073	2038-08-23	U-2224		2021-08-04
N208944-001	11077073	2038-08-23	U-3180		2021-08-04
N208944-001	12233033	2038-08-23	U-2106		2025-03-25
N208944-001	12233033	2038-08-23	U-2224		2025-03-25
N208944-001	12233033	2038-08-23	U-3180		2025-03-25
N208944-002	8389578	2028-01-22	U-2105		2017-09-21
N208944-002	11197835	2030-12-02	U-2106		2022-01-12
N208944-002	8741343	2030-12-02	U-2106		2017-09-21
N208944-002	9867791	2030-12-02	U-2106		2018-01-16
N208944-002	9867792	2030-12-02	U-2106		2018-01-16
N208944-002	9867793	2030-12-02	U-2106		2018-01-16
N208944-002	9877933	2030-12-02	U-2224		2018-01-30
N208944-002	10646456	2034-06-17	U-2808		2020-07-14
N208944-002	11903908	2034-06-17	U-3822		2024-03-08
N208944-002	10154971	2034-12-04	U-2459		2018-12-18
N208944-002	11065213	2038-08-23		Drug product	2021-07-20
N208944-002	11077073	2038-08-23	U-2106		2021-08-04
N208944-002	11077073	2038-08-23	U-2224		2021-08-04
N208944-002	11077073	2038-08-23	U-3180		2021-08-04
N208944-002	12233033	2038-08-23	U-2106		2025-03-25
N208944-002	12233033	2038-08-23	U-2224		2025-03-25
N208944-002	12233033	2038-08-23	U-3180		2025-03-25

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 3 · 84 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	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2017-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2017-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2017-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2017-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2017-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2017-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2017-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208944-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208944-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208944-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208944-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208944-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208944-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208944-001	AB	1	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 41 · 1,610 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208944-001	8389578	2028-01-22	U-2105		2017-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-001	11197835	2030-12-02	U-2106		2022-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-001	8741343	2030-12-02	U-2106		2017-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-001	9867791	2030-12-02	U-2106		2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-001	9867792	2030-12-02	U-2106		2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-001	9867793	2030-12-02	U-2106		2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-001	9877933	2030-12-02	U-2224		2018-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-001	10646456	2034-06-17	U-2808		2020-07-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-001	11903908	2034-06-17	U-3822		2024-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-001	10154971	2034-12-04	U-2459		2018-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-001	11065213	2038-08-23		Drug product	2021-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-001	11077073	2038-08-23	U-2106		2021-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-001	11077073	2038-08-23	U-2224		2021-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-001	11077073	2038-08-23	U-3180		2021-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-001	12233033	2038-08-23	U-2106		2025-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-001	12233033	2038-08-23	U-3180		2025-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-001	12233033	2038-08-23	U-2224		2025-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-002	8389578	2028-01-22	U-2105		2017-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-002	11197835	2030-12-02	U-2106		2022-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-002	8741343	2030-12-02	U-2106		2017-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-002	9867791	2030-12-02	U-2106		2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-002	9867792	2030-12-02	U-2106		2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-002	9867793	2030-12-02	U-2106		2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-002	9877933	2030-12-02	U-2224		2018-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-002	10646456	2034-06-17	U-2808		2020-07-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-002	11903908	2034-06-17	U-3822		2024-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-002	10154971	2034-12-04	U-2459		2018-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-002	11065213	2038-08-23		Drug product	2021-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-002	11077073	2038-08-23	U-2224		2021-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-002	11077073	2038-08-23	U-3180		2021-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-002	11077073	2038-08-23	U-2106		2021-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-002	12233033	2038-08-23	U-2224		2025-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-002	12233033	2038-08-23	U-2106		2025-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-002	12233033	2038-08-23	U-3180		2025-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208944-001	8389578	2028-01-22	U-2105		2017-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208944-001	11197835	2030-12-02	U-2106		2022-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208944-001	8741343	2030-12-02	U-2106		2017-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208944-001	9867791	2030-12-02	U-2106		2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208944-001	9867792	2030-12-02	U-2106		2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208944-001	9867793	2030-12-02	U-2106		2018-01-16	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208944-001	ODE-153	2024-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208944-002	ODE-153	2024-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208944-001	ODE-153	2024-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208944-002	ODE-153	2024-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208944-001	ODE-153	2024-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208944-002	ODE-153	2024-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208944-001	ODE-153	2024-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208944-002	ODE-153	2024-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208944-001	ODE-153	2024-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208944-002	ODE-153	2024-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208944-001	ODE-153	2024-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208944-002	ODE-153	2024-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208944-001	ODE-153	2024-08-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208944-002	ODE-153	2024-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208944-001	ODE-153	2024-08-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208944-002	ODE-153	2024-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208944-001	ODE-153	2024-08-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208944-002	ODE-153	2024-08-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208944-001	ODE-153	2024-08-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208944-002	ODE-153	2024-08-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208944-001	ODE-153	2024-08-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208944-002	ODE-153	2024-08-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208944-001	ODE-153	2024-08-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208944-002	ODE-153	2024-08-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208944-001	I-769	2020-08-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208944-001	ODE-153	2024-08-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208944-002	I-769	2020-08-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208944-002	ODE-153	2024-08-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208944-001	ODE-153	2024-08-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208944-002	ODE-153	2024-08-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208944-001	ODE-153	2024-08-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208944-002	ODE-153	2024-08-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208944-001	ODE-153	2024-08-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208944-002	ODE-153	2024-08-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208944-001	ODE-153	2024-08-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208944-002	ODE-153	2024-08-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208944-001	I-769	2020-08-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208944-001	ODE-153	2024-08-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208944-002	I-769	2020-08-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208944-002	ODE-153	2024-08-24	`8869cabd3fbd…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMANTADINE	68.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BF4C9Z1J53	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1944370	Internal RxNorm lookup
1944376	Internal RxNorm lookup
1944380	Internal RxNorm lookup
1944382	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
82ff865f-78f3-4c94-b6a9-727a54944b28	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70482-085-21	2024-02-08	GOCOVRI ® - These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI. GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968
70482-085-21	2024-02-08	These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI ® . GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968
70482-085-60	2024-02-08	GOCOVRI ® - These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI. GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968
70482-085-60	2024-02-08	These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI ® . GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968
70482-085-61	2024-02-08	GOCOVRI ® - These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI. GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968
70482-085-61	2024-02-08	These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI ® . GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968
70482-085-21	2024-01-30	GOCOVRI ® - These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI. GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968
70482-085-21	2024-01-30	These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI ® . GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968
70482-085-60	2024-01-30	GOCOVRI ® - These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI. GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968
70482-085-60	2024-01-30	These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI ® . GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968
70482-085-61	2024-01-30	GOCOVRI ® - These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI. GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968
70482-085-61	2024-01-30	These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI ® . GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70482-085-21	GOCOVRI	21 in 1 BOTTLE	CAPSULE, COATED PELLETS	21	17
70482-085-60	GOCOVRI	60 in 1 BOTTLE	CAPSULE, COATED PELLETS	60	17
70482-085-61	GOCOVRI	60 in 1 BOTTLE	CAPSULE, COATED PELLETS	60	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70482-085-60	EA - Each	70482-085	03ed5b83-ee9a-410d-8aef-60997dd00cf2	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70482-085	GOCOVRI (AMANTADINE) CAPSULE, COATED PELLETS [ADAMAS PHARMA, LLC]	13	Current NDC, Legacy NDC, 3 package rows	20241012_82ff865f-78f3-4c94-b6a9-727a54944b28.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GOCOVRI	AMANTADINE	Supernus Pharmaceuticals	2bee0631-0028-1314-e063-6394a90aaaed	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208944 application number: NDA208944
GOCOVRI	AMANTADINE	Adamas Pharma, LLC	82ff865f-78f3-4c94-b6a9-727a54944b28	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208944 application number: NDA208944 ndc (product): 70482-085

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BF4C9Z1J53	AMANTADINE	768-94-5	AMANTADINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1944370	amantadine 137 MG 24HR Extended Release Oral Capsule	PSN	82ff865f-78f3-4c94-b6a9-727a54944b28	17
1944380	amantadine 68.5 MG 24HR Extended Release Oral Capsule	PSN	82ff865f-78f3-4c94-b6a9-727a54944b28	17
1944376	GOCOVRI 137 MG 24HR Extended Release Oral Capsule	PSN	82ff865f-78f3-4c94-b6a9-727a54944b28	17
1944382	GOCOVRI 68.5 MG 24HR Extended Release Oral Capsule	PSN	82ff865f-78f3-4c94-b6a9-727a54944b28	17
1944376	24 HR amantadine 137 MG Extended Release Oral Capsule [Gocovri]	SBD	82ff865f-78f3-4c94-b6a9-727a54944b28	17
1944382	24 HR amantadine 68.5 MG Extended Release Oral Capsule [Gocovri]	SBD	82ff865f-78f3-4c94-b6a9-727a54944b28	17
1944370	24 HR amantadine 137 MG Extended Release Oral Capsule	SCD	82ff865f-78f3-4c94-b6a9-727a54944b28	17
1944380	24 HR amantadine 68.5 MG Extended Release Oral Capsule	SCD	82ff865f-78f3-4c94-b6a9-727a54944b28	17
1944376	24 HR Gocovri 137 MG Extended Release Oral Capsule	SY	82ff865f-78f3-4c94-b6a9-727a54944b28	17
1944382	24 HR Gocovri 68.5 MG Extended Release Oral Capsule	SY	82ff865f-78f3-4c94-b6a9-727a54944b28	17
1944370	amantadine 137 MG (as amantadine HCl 170 MG) 24 HR Extended Release Oral Capsule	SY	82ff865f-78f3-4c94-b6a9-727a54944b28	17
1944380	amantadine 68.5 MG (as amantadine HCl 85 MG) 24 HR Extended Release Oral Capsule	SY	82ff865f-78f3-4c94-b6a9-727a54944b28	17
1944376	Gocovri 137 MG (as amantadine HCl 170 MG) 24 HR Extended Release Oral Capsule	SY	82ff865f-78f3-4c94-b6a9-727a54944b28	17
1944382	Gocovri 68.5 MG (amantadine HCl 85 MG) 24 HR Extended Release Oral Capsule	SY	82ff865f-78f3-4c94-b6a9-727a54944b28	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70482-085-21	70482008521	21 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-21)	2017-08-24	0000-00-00	Yes	No	Current
70482-085-60	70482008560	60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-60)	2017-08-24	0000-00-00	No	No	Current
70482-085-61	70482008561	60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-61)	2017-08-24	0000-00-00	Yes	No	Current