Armodafinil

Product NDC: 68788-7426
11-digit product format: 687887426
Labeler code: 68788
Product ID: 68788-7426_d50a8f0a-965b-4b3b-8983-2069dc4c20af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Armodafinil
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA206069
Marketing category: ANDA
Marketing start: 2018-03-06
Marketing end: 0000-00-00
Substance: ARMODAFINIL
Active strength: 150 mg/1
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

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

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-7426		D	Discontinued by firm	2026-08-17
excluded package	package	68788-7426	68788-7426-3	D	Discontinued by firm	2026-08-17
excluded package	package	68788-7426	68788-7426-6	D	Discontinued by firm	2026-08-17
excluded package	package	68788-7426	68788-7426-9	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 · 48 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	68788-7426-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7426-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7426-6	`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	68788-7426-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7426-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7426-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7426-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7426-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7426-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7426-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7426-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7426-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7426-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7426-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7426-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7426-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7426-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7426-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7426-9	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7426-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7426-6	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7426-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7426-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7426-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7426-9	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7426-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7426-6	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7426-9	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7426-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7426-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68788-7426-9	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68788-7426-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68788-7426-6	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68788-7426-9	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68788-7426-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68788-7426-6	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	TE codes	Approval date
A206069-001	ARMODAFINIL	ARMODAFINIL	50MG	TABLET / ORAL	AB	2018-03-06
A206069-002	ARMODAFINIL	ARMODAFINIL	150MG	TABLET / ORAL	AB	2018-03-06
A206069-003	ARMODAFINIL	ARMODAFINIL	250MG	TABLET / ORAL	AB	2018-03-06
A206069-004	ARMODAFINIL	ARMODAFINIL	200MG	TABLET / ORAL	AB	2018-12-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A206069-001	AB
A206069-002	AB
A206069-003	AB
A206069-004	AB

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 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A206069-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206069-002	ARMODAFINIL	150MG	TABLET / ORAL	AB	2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206069-003	ARMODAFINIL	250MG	TABLET / ORAL	AB	2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206069-004	ARMODAFINIL	200MG	TABLET / ORAL	AB	2018-12-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206069-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2018-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206069-002	ARMODAFINIL	150MG	TABLET / ORAL	AB	2018-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206069-003	ARMODAFINIL	250MG	TABLET / ORAL	AB	2018-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206069-004	ARMODAFINIL	200MG	TABLET / ORAL	AB	2018-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206069-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2018-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206069-002	ARMODAFINIL	150MG	TABLET / ORAL	AB	2018-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206069-003	ARMODAFINIL	250MG	TABLET / ORAL	AB	2018-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206069-004	ARMODAFINIL	200MG	TABLET / ORAL	AB	2018-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206069-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2018-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206069-002	ARMODAFINIL	150MG	TABLET / ORAL	AB	2018-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206069-003	ARMODAFINIL	250MG	TABLET / ORAL	AB	2018-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206069-004	ARMODAFINIL	200MG	TABLET / ORAL	AB	2018-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206069-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2018-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206069-002	ARMODAFINIL	150MG	TABLET / ORAL	AB	2018-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206069-003	ARMODAFINIL	250MG	TABLET / ORAL	AB	2018-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206069-004	ARMODAFINIL	200MG	TABLET / ORAL	AB	2018-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206069-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2018-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206069-002	ARMODAFINIL	150MG	TABLET / ORAL	AB	2018-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206069-003	ARMODAFINIL	250MG	TABLET / ORAL	AB	2018-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206069-004	ARMODAFINIL	200MG	TABLET / ORAL	AB	2018-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206069-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2018-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206069-002	ARMODAFINIL	150MG	TABLET / ORAL	AB	2018-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206069-003	ARMODAFINIL	250MG	TABLET / ORAL	AB	2018-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206069-004	ARMODAFINIL	200MG	TABLET / ORAL	AB	2018-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206069-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2018-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206069-002	ARMODAFINIL	150MG	TABLET / ORAL	AB	2018-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206069-003	ARMODAFINIL	250MG	TABLET / ORAL	AB	2018-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206069-004	ARMODAFINIL	200MG	TABLET / ORAL	AB	2018-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206069-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2018-03-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206069-002	ARMODAFINIL	150MG	TABLET / ORAL	AB	2018-03-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206069-003	ARMODAFINIL	250MG	TABLET / ORAL	AB	2018-03-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206069-004	ARMODAFINIL	200MG	TABLET / ORAL	AB	2018-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206069-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2018-03-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206069-002	ARMODAFINIL	150MG	TABLET / ORAL	AB	2018-03-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206069-003	ARMODAFINIL	250MG	TABLET / ORAL	AB	2018-03-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206069-004	ARMODAFINIL	200MG	TABLET / ORAL	AB	2018-12-07	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206069-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206069-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206069-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206069-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206069-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206069-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206069-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206069-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206069-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206069-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206069-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206069-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206069-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206069-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206069-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206069-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206069-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206069-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206069-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206069-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206069-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206069-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206069-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206069-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206069-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206069-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206069-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206069-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206069-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206069-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206069-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206069-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206069-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206069-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206069-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206069-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206069-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206069-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206069-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206069-004	AB	1	`d8e5a09893c0…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68788-7426-3	2021-02-03	These highlights do not include all the information needed to use ARMODAFINIL TABLETS safely and effectively. See full prescribing information for ARMODAFINIL TABLETS. ARMODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 2007
68788-7426-6	2021-02-03	These highlights do not include all the information needed to use ARMODAFINIL TABLETS safely and effectively. See full prescribing information for ARMODAFINIL TABLETS. ARMODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 2007
68788-7426-9	2021-02-03	These highlights do not include all the information needed to use ARMODAFINIL TABLETS safely and effectively. See full prescribing information for ARMODAFINIL TABLETS. ARMODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 2007
68788-7426-3	2021-01-29	These highlights do not include all the information needed to use ARMODAFINIL TABLETS safely and effectively. See full prescribing information for ARMODAFINIL TABLETS. ARMODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 2007
68788-7426-6	2021-01-29	These highlights do not include all the information needed to use ARMODAFINIL TABLETS safely and effectively. See full prescribing information for ARMODAFINIL TABLETS. ARMODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 2007
68788-7426-9	2021-01-29	These highlights do not include all the information needed to use ARMODAFINIL TABLETS safely and effectively. See full prescribing information for ARMODAFINIL TABLETS. ARMODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 2007

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Armodafinil	ARMODAFINIL	Preferred Pharmaceuticals Inc.	93b9f9a4-66d9-4ed9-8f2f-903e416e900d	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206069 application number: ANDA206069
Armodafinil	ARMODAFINIL	Preferred Pharmaceuticals Inc.	4128759d-ed7c-4130-b24c-a0541f2b9e7f	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206069 application number: ANDA206069
Armodafinil	ARMODAFINIL	Direct_Rx	facd329b-1925-61df-e053-6294a90ab738	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206069 application number: ANDA206069
ARMODAFINIL	ARMODAFINIL	direct rx	b1ba1cdd-cf57-7a8c-e053-2a95a90a2c19	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206069 application number: ANDA206069
Armodafinil	ARMODAFINIL	Bryant Ranch Prepack	cbe7c0d9-dfd2-4000-bd76-7fe3454ce64f	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206069 application number: ANDA206069
Armodafinil	ARMODAFINIL	Aurobindo Pharma Limited	23da56b8-7552-4362-a1ab-e794c131194c	2024-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206069 application number: ANDA206069