OSMOLEX ER

Product NDC: 70482-075
11-digit product format: 704820075
Labeler code: 70482
Product ID: 70482-075_8321bb20-293e-4848-b1be-3116bf9ca476
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amantadine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Adamas Pharma, LLC
Application: NDA209410
Marketing category: NDA
Marketing start: 2018-06-01
Marketing end: 0000-00-00
Substance: AMANTADINE HYDROCHLORIDE
Active strength: 129 mg/1
Pharmacologic classes: Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70482-075		D	Discontinued by firm	2026-08-17
excluded package	package	70482-075	70482-075-07	D	Discontinued by firm	2026-08-17
excluded package	package	70482-075	70482-075-14	D	Discontinued by firm	2026-08-17
excluded package	package	70482-075	70482-075-30	D	Discontinued by firm	2026-08-17

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 · 8 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	70482-075-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70482-075-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70482-075-07	`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	70482-075-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70482-075-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70482-075-07	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N209410-001	OSMOLEX ER	AMANTADINE HYDROCHLORIDE	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16
N209410-002	OSMOLEX ER	AMANTADINE HYDROCHLORIDE	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16
N209410-003	OSMOLEX ER	AMANTADINE HYDROCHLORIDE	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16
N209410-004	OSMOLEX ER	AMANTADINE HYDROCHLORIDE	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22

Orange Book patents#

Current patent rows page 1 of 1 · 38 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209410-001	8389578	2028-01-22	U-219		2021-02-10
N209410-001	8389578	2028-01-22	U-3054		2021-02-10
N209410-001	8252331	2030-03-13		Drug product	2018-03-01
N209410-001	10213393	2038-02-15	U-20		2019-03-13
N209410-001	10213394	2038-02-15	U-2497		2019-03-13
N209410-001	10500170	2038-02-15	U-20		2019-12-17
N209410-001	10500171	2038-02-15	U-2497		2019-12-17
N209410-001	10500172	2038-02-15	U-2497		2019-12-17
N209410-001	10512617	2038-02-15	U-2497		2020-01-02
N209410-001	11890261	2038-02-15	U-2497		2024-03-04
N209410-002	8389578	2028-01-22	U-219		2021-02-10
N209410-002	8389578	2028-01-22	U-3054		2021-02-10
N209410-002	8252331	2030-03-13		Drug product	2018-03-01
N209410-002	10213393	2038-02-15	U-20		2019-03-13
N209410-002	10213394	2038-02-15	U-2497		2019-03-13
N209410-002	10500170	2038-02-15	U-20		2019-12-17
N209410-002	10500171	2038-02-15	U-2497		2019-12-17
N209410-002	10500172	2038-02-15	U-2497		2019-12-17
N209410-002	10512617	2038-02-15	U-2497		2020-01-02
N209410-002	11890261	2038-02-15	U-2497		2024-03-04
N209410-003	8389578	2028-01-22	U-219		2021-02-10
N209410-003	8389578	2028-01-22	U-3054		2021-02-10
N209410-003	8252331	2030-03-13		Drug product	2018-03-01
N209410-003	10213393	2038-02-15	U-20		2019-03-13
N209410-003	10213394	2038-02-15	U-2497		2019-03-13
N209410-003	10500170	2038-02-15	U-20		2019-12-17
N209410-003	10500171	2038-02-15	U-2497		2019-12-17
N209410-003	10500172	2038-02-15	U-2497		2019-12-17
N209410-003	10512617	2038-02-15	U-2497		2020-01-02
N209410-004	8389578	2028-01-22	U-219		2021-02-10
N209410-004	8389578	2028-01-22	U-3054		2021-02-10
N209410-004	8252331	2030-03-13		Drug product	2020-10-29
N209410-004	10213393	2038-02-15	U-20		2020-10-29
N209410-004	10213394	2038-02-15	U-2497		2020-10-29
N209410-004	10500170	2038-02-15	U-20		2020-10-29
N209410-004	10500171	2038-02-15	U-2497		2020-10-29
N209410-004	10500172	2038-02-15	U-2497		2020-10-29
N209410-004	10512617	2038-02-15	U-2497		2020-10-29

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209410-001	OSMOLEX ER	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-002	OSMOLEX ER	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-003	OSMOLEX ER	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-004	OSMOLEX ER	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209410-001	OSMOLEX ER	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-002	OSMOLEX ER	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-003	OSMOLEX ER	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-004	OSMOLEX ER	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209410-001	OSMOLEX ER	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209410-002	OSMOLEX ER	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209410-003	OSMOLEX ER	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209410-004	OSMOLEX ER	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209410-001	OSMOLEX ER	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209410-002	OSMOLEX ER	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209410-003	OSMOLEX ER	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209410-004	OSMOLEX ER	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209410-001	OSMOLEX ER	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209410-002	OSMOLEX ER	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209410-003	OSMOLEX ER	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209410-004	OSMOLEX ER	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209410-001	OSMOLEX ER	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209410-002	OSMOLEX ER	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209410-003	OSMOLEX ER	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209410-004	OSMOLEX ER	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209410-001	OSMOLEX ER	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209410-002	OSMOLEX ER	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209410-003	OSMOLEX ER	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209410-004	OSMOLEX ER	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209410-001	OSMOLEX ER	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209410-002	OSMOLEX ER	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209410-003	OSMOLEX ER	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209410-004	OSMOLEX ER	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209410-001	OSMOLEX ER	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209410-002	OSMOLEX ER	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209410-003	OSMOLEX ER	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209410-004	OSMOLEX ER	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209410-001	OSMOLEX ER	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209410-002	OSMOLEX ER	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209410-003	OSMOLEX ER	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209410-004	OSMOLEX ER	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 89 · 3,546 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	N209410-001	8389578	2028-01-22	U-3054		2021-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-001	8389578	2028-01-22	U-219		2021-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-001	8252331	2030-03-13		Drug product	2018-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-001	10213393	2038-02-15	U-20		2019-03-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-001	10213394	2038-02-15	U-2497		2019-03-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-001	10500170	2038-02-15	U-20		2019-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-001	10500171	2038-02-15	U-2497		2019-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-001	10500172	2038-02-15	U-2497		2019-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-001	10512617	2038-02-15	U-2497		2020-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-001	11890261	2038-02-15	U-2497		2024-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-002	8389578	2028-01-22	U-219		2021-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-002	8389578	2028-01-22	U-3054		2021-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-002	8252331	2030-03-13		Drug product	2018-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-002	10213393	2038-02-15	U-20		2019-03-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-002	10213394	2038-02-15	U-2497		2019-03-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-002	10500170	2038-02-15	U-20		2019-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-002	10500171	2038-02-15	U-2497		2019-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-002	10500172	2038-02-15	U-2497		2019-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-002	10512617	2038-02-15	U-2497		2020-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-002	11890261	2038-02-15	U-2497		2024-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-003	8389578	2028-01-22	U-219		2021-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-003	8389578	2028-01-22	U-3054		2021-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-003	8252331	2030-03-13		Drug product	2018-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-003	10213393	2038-02-15	U-20		2019-03-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-003	10213394	2038-02-15	U-2497		2019-03-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-003	10500170	2038-02-15	U-20		2019-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-003	10500171	2038-02-15	U-2497		2019-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-003	10500172	2038-02-15	U-2497		2019-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-003	10512617	2038-02-15	U-2497		2020-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-004	8389578	2028-01-22	U-3054		2021-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-004	8389578	2028-01-22	U-219		2021-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-004	8252331	2030-03-13		Drug product	2020-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-004	10213393	2038-02-15	U-20		2020-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-004	10213394	2038-02-15	U-2497		2020-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-004	10500170	2038-02-15	U-20		2020-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-004	10500171	2038-02-15	U-2497		2020-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-004	10500172	2038-02-15	U-2497		2020-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-004	10512617	2038-02-15	U-2497		2020-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209410-001	8389578	2028-01-22	U-3054		2021-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-001	8389578	2028-01-22	U-219		2021-02-10	`011fe1cb6892…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70482-075-07	2024-02-08	OSMOLEX ®ER - These highlights do not include all the information needed to use OSMOLEX ER safely and effectively. See full prescribing information for OSMOLEX ER. OSMOLEX ® ER (amantadine) extended-release tablets, for oral use Initial U.S. Approval: 1966
70482-075-14	2024-02-08	OSMOLEX ®ER - These highlights do not include all the information needed to use OSMOLEX ER safely and effectively. See full prescribing information for OSMOLEX ER. OSMOLEX ® ER (amantadine) extended-release tablets, for oral use Initial U.S. Approval: 1966
70482-075-30	2024-02-08	OSMOLEX ®ER - These highlights do not include all the information needed to use OSMOLEX ER safely and effectively. See full prescribing information for OSMOLEX ER. OSMOLEX ® ER (amantadine) extended-release tablets, for oral use Initial U.S. Approval: 1966
70482-075-07	2024-01-30	OSMOLEX ®ER - These highlights do not include all the information needed to use OSMOLEX ER safely and effectively. See full prescribing information for OSMOLEX ER. OSMOLEX ® ER (amantadine) extended-release tablets, for oral use Initial U.S. Approval: 1966
70482-075-14	2024-01-30	OSMOLEX ®ER - These highlights do not include all the information needed to use OSMOLEX ER safely and effectively. See full prescribing information for OSMOLEX ER. OSMOLEX ® ER (amantadine) extended-release tablets, for oral use Initial U.S. Approval: 1966
70482-075-30	2024-01-30	OSMOLEX ®ER - These highlights do not include all the information needed to use OSMOLEX ER safely and effectively. See full prescribing information for OSMOLEX ER. OSMOLEX ® ER (amantadine) extended-release tablets, for oral use Initial U.S. Approval: 1966

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70482-075-30	EA - Each	70482-075	00a4cce2-8de3-4f7c-81b1-396d8ebc97cd	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70482-075	OSMOLEX ER (AMANTADINE) TABLET, EXTENDED RELEASE [ADAMAS PHARMA, LLC]	10	Legacy NDC	20241012_6fbddb66-8b9d-4d37-a348-abcc31276e89.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M6Q1EO9TD0	AMANTADINE HYDROCHLORIDE	665-66-7	AMANTADINE HYDROCHLORIDE
BF4C9Z1J53	AMANTADINE	768-94-5	amantadine

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70482-075-07	70482007507	2 BLISTER PACK in 1 CARTON (70482-075-07) > 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2 blister pack	2018-06-01	0000-00-00	Yes	No	Current
70482-075-14	70482007514	14 TABLET, EXTENDED RELEASE in 1 BOTTLE (70482-075-14)		2018-06-01	0000-00-00	Yes	No	Current
70482-075-30	70482007530	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70482-075-30)		2018-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OSMOLEX ER	Adamas Pharma, LLC \| Osmotica Pharmaceutical US LLC	2024-10-10	HUMAN PRESCRIPTION DRUG LABEL	10