GOCOVRI

Product NDC: 70482-170
11-digit product format: 704820170
Labeler code: 70482
Product ID: 70482-170_5d1a08df-97ef-bfb9-e063-6394a90a1707
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: 137 mg/1
Pharmacologic classes: Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 88 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
2026-10-15 13:18:30	2026-09	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`84e616aacf4f…`
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…`

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 42 · 1,678 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N208944-001	8389578	2028-01-22	U-2105		2017-09-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	11197835	2030-12-02	U-2106		2022-01-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	8741343	2030-12-02	U-2106		2017-09-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	9867791	2030-12-02	U-2106		2018-01-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	9867792	2030-12-02	U-2106		2018-01-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	9867793	2030-12-02	U-2106		2018-01-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	9877933	2030-12-02	U-2224		2018-01-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	10646456	2034-06-17	U-2808		2020-07-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	11903908	2034-06-17	U-3822		2024-03-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	10154971	2034-12-04	U-2459		2018-12-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	11065213	2038-08-23		Drug product	2021-07-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	11077073	2038-08-23	U-2106		2021-08-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	11077073	2038-08-23	U-2224		2021-08-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	11077073	2038-08-23	U-3180		2021-08-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	12233033	2038-08-23	U-2106		2025-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	12233033	2038-08-23	U-3180		2025-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	12233033	2038-08-23	U-2224		2025-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	8389578	2028-01-22	U-2105		2017-09-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	11197835	2030-12-02	U-2106		2022-01-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	8741343	2030-12-02	U-2106		2017-09-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	9867791	2030-12-02	U-2106		2018-01-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	9867792	2030-12-02	U-2106		2018-01-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	9867793	2030-12-02	U-2106		2018-01-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	9877933	2030-12-02	U-2224		2018-01-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	10646456	2034-06-17	U-2808		2020-07-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	11903908	2034-06-17	U-3822		2024-03-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	10154971	2034-12-04	U-2459		2018-12-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	11065213	2038-08-23		Drug product	2021-07-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	11077073	2038-08-23	U-2224		2021-08-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	11077073	2038-08-23	U-3180		2021-08-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	11077073	2038-08-23	U-2106		2021-08-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	12233033	2038-08-23	U-2224		2025-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	12233033	2038-08-23	U-2106		2025-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	12233033	2038-08-23	U-3180		2025-03-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208944-001	8389578	2028-01-22	U-2105		2017-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208944-001	11197835	2030-12-02	U-2106		2022-01-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208944-001	8741343	2030-12-02	U-2106		2017-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208944-001	9867791	2030-12-02	U-2106		2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208944-001	9867792	2030-12-02	U-2106		2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208944-001	9867793	2030-12-02	U-2106		2018-01-16	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2020-11-12 02:37 UTC	2020-11	N208944-001	I-769	2020-08-24	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208944-001	ODE-153	2024-08-24	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208944-002	I-769	2020-08-24	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208944-002	ODE-153	2024-08-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208944-001	I-769	2020-08-24	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208944-001	ODE-153	2024-08-24	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208944-002	I-769	2020-08-24	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208944-002	ODE-153	2024-08-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208944-001	I-769	2020-08-24	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208944-001	ODE-153	2024-08-24	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208944-002	I-769	2020-08-24	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208944-002	ODE-153	2024-08-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208944-001	I-769	2020-08-24	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208944-001	ODE-153	2024-08-24	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208944-002	I-769	2020-08-24	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208944-002	ODE-153	2024-08-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208944-001	ODE-153	2024-08-24	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208944-002	ODE-153	2024-08-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208944-001	ODE-153	2024-08-24	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N208944-002	ODE-153	2024-08-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208944-001	ODE-153	2024-08-24	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N208944-002	ODE-153	2024-08-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208944-001	ODE-153	2024-08-24	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208944-002	ODE-153	2024-08-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208944-001	ODE-153	2024-08-24	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208944-002	ODE-153	2024-08-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208944-001	ODE-153	2024-08-24	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208944-002	ODE-153	2024-08-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208944-001	ODE-153	2024-08-24	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208944-002	ODE-153	2024-08-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208944-001	ODE-153	2024-08-24	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N208944-002	ODE-153	2024-08-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208944-001	ODE-153	2024-08-24	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N208944-002	ODE-153	2024-08-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208944-001	ODE-153	2024-08-24	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208944-002	ODE-153	2024-08-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208944-001	ODE-153	2024-08-24	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N208944-002	ODE-153	2024-08-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208944-001	ODE-153	2024-08-24	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N208944-002	ODE-153	2024-08-24	`e64feba35796…`

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: GOCOVRI
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMANTADINE	137 mg/1

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
70482-170-21	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
70482-170-21	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
70482-170-21	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
70482-170-21	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
70482-170-21	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
70482-170-60	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
70482-170-60	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
70482-170-60	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
70482-170-60	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
70482-170-60	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
70482-170-61	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
70482-170-61	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
70482-170-61	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
70482-170-61	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
70482-170-61	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
70482-170-21	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
70482-170-21	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
70482-170-21	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
70482-170-21	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
70482-170-21	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
70482-170-60	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
70482-170-60	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
70482-170-60	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
70482-170-60	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
70482-170-60	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
70482-170-61	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
70482-170-61	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
70482-170-61	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
70482-170-61	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
70482-170-61	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
70482-170-21	GOCOVRI	21 in 1 BOTTLE	CAPSULE, COATED PELLETS	21	17
70482-170-60	GOCOVRI	60 in 1 BOTTLE	CAPSULE, COATED PELLETS	60	17
70482-170-61	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
70482-170-60	EA - Each	70482-170	0953b258-0b36-40d1-ad83-644d30fc8c75	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70482-170	GOCOVRI (AMANTADINE) CAPSULE, COATED PELLETS [ADAMAS PHARMA, LLC]	13	Current NDC, Legacy NDC, 3 package rows	20241012_82ff865f-78f3-4c94-b6a9-727a54944b28.zip

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
70482-170-21	70482017021	21 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-170-21)	2017-08-24	0000-00-00	Yes	No	Current
70482-170-60	70482017060	60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-170-60)	2017-08-24	0000-00-00	No	No	Current
70482-170-61	70482017061	60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-170-61)	2017-08-24	0000-00-00	Yes	No	Current