Nuvigil

Product NDC: 63459-225
11-digit product format: 634590225
Labeler code: 63459
Product ID: 63459-225_a70488d7-57ea-446e-89c2-87b0ecc90023
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Armodafinil
Dosage form: TABLET
Route: ORAL
Labeler: Cephalon, LLC
Application: NDA021875
Marketing category: NDA
Marketing start: 2009-05-26
Marketing end: 2026-06-30
Substance: ARMODAFINIL
Active strength: 250 mg/1
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
unfinished product	product	63459-225		UNFINISHED	Active or certified unfinished drug listing	2026-08-17
unfinished package	package	63459-225	63459-225-99	UNFINISHED	Active or certified unfinished drug listing	2026-08-17
excluded product	product	63459-225		D	Discontinued by firm	2026-08-17
excluded package	package	63459-225	63459-225-30	D	Discontinued by firm	2026-08-17
excluded package	package	63459-225	63459-225-35	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 · 40 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	63459-225-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63459-225-35	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63459-225-35	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	63459-225-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	63459-225-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	63459-225-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	63459-225-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	63459-225-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	63459-225-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	63459-225-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	63459-225-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	63459-225-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	63459-225-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	63459-225-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	63459-225-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	63459-225-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	63459-225-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	63459-225-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	63459-225-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	63459-225-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	63459-225-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021875-001	NUVIGIL	ARMODAFINIL	50MG	TABLET / ORAL	AB	RLD	2007-06-15
N021875-002	NUVIGIL	ARMODAFINIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-03-26
N021875-003	NUVIGIL	ARMODAFINIL	150MG	TABLET / ORAL	AB	RLD	2007-06-15
N021875-004	NUVIGIL	ARMODAFINIL	250MG	TABLET / ORAL	AB	RLD, RS	2007-06-15
N021875-005	NUVIGIL	ARMODAFINIL	200MG	TABLET / ORAL	AB	RLD	2009-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021875-001	AB
N021875-003	AB
N021875-004	AB
N021875-005	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 6 · 210 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	N021875-001	NUVIGIL	50MG	TABLET / ORAL	AB	RLD	2007-06-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021875-002	NUVIGIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021875-003	NUVIGIL	150MG	TABLET / ORAL	AB	RLD	2007-06-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021875-004	NUVIGIL	250MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021875-005	NUVIGIL	200MG	TABLET / ORAL	AB	RLD	2009-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021875-001	NUVIGIL	50MG	TABLET / ORAL	AB	RLD	2007-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021875-002	NUVIGIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021875-003	NUVIGIL	150MG	TABLET / ORAL	AB	RLD	2007-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021875-004	NUVIGIL	250MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021875-005	NUVIGIL	200MG	TABLET / ORAL	AB	RLD	2009-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021875-001	NUVIGIL	50MG	TABLET / ORAL	AB	RLD	2007-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021875-002	NUVIGIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021875-003	NUVIGIL	150MG	TABLET / ORAL	AB	RLD	2007-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021875-004	NUVIGIL	250MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021875-005	NUVIGIL	200MG	TABLET / ORAL	AB	RLD	2009-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021875-001	NUVIGIL	50MG	TABLET / ORAL	AB	RLD	2007-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021875-002	NUVIGIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021875-003	NUVIGIL	150MG	TABLET / ORAL	AB	RLD	2007-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021875-004	NUVIGIL	250MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021875-005	NUVIGIL	200MG	TABLET / ORAL	AB	RLD	2009-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021875-001	NUVIGIL	50MG	TABLET / ORAL	AB	RLD	2007-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021875-002	NUVIGIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021875-003	NUVIGIL	150MG	TABLET / ORAL	AB	RLD	2007-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021875-004	NUVIGIL	250MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021875-005	NUVIGIL	200MG	TABLET / ORAL	AB	RLD	2009-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021875-001	NUVIGIL	50MG	TABLET / ORAL	AB	RLD	2007-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021875-002	NUVIGIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021875-003	NUVIGIL	150MG	TABLET / ORAL	AB	RLD	2007-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021875-004	NUVIGIL	250MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021875-005	NUVIGIL	200MG	TABLET / ORAL	AB	RLD	2009-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-001	NUVIGIL	50MG	TABLET / ORAL	AB	RLD	2007-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-002	NUVIGIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-003	NUVIGIL	150MG	TABLET / ORAL	AB	RLD	2007-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-004	NUVIGIL	250MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-005	NUVIGIL	200MG	TABLET / ORAL	AB	RLD	2009-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-001	NUVIGIL	50MG	TABLET / ORAL	AB	RLD	2007-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-002	NUVIGIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-003	NUVIGIL	150MG	TABLET / ORAL	AB	RLD	2007-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-004	NUVIGIL	250MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-005	NUVIGIL	200MG	TABLET / ORAL	AB	RLD	2009-03-26	`2680178bc6a6…`

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	N021875-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021875-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021875-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021875-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021875-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021875-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021875-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021875-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021875-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021875-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021875-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021875-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021875-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021875-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021875-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021875-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021875-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021875-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021875-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021875-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021875-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021875-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021875-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021875-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-005	AB	1	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 590 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-001	7297346*PED	2024-05-29	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-001	7132570*PED	2024-06-18	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-002	7297346*PED	2024-05-29	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-002	7132570*PED	2024-06-18	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-003	7297346*PED	2024-05-29	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-003	7132570*PED	2024-06-18	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-004	7297346*PED	2024-05-29	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-004	7132570*PED	2024-06-18	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-005	7297346*PED	2024-05-29	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-005	7132570*PED	2024-06-18	Pediatric extension	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-001	7297346*PED	2024-05-29	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-001	7132570*PED	2024-06-18	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-002	7297346*PED	2024-05-29	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-002	7132570*PED	2024-06-18	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-003	7297346*PED	2024-05-29	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-003	7132570*PED	2024-06-18	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-004	7297346*PED	2024-05-29	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-004	7132570*PED	2024-06-18	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-005	7297346*PED	2024-05-29	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-005	7132570*PED	2024-06-18	Pediatric extension	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-001	7297346*PED	2024-05-29	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-001	7132570*PED	2024-06-18	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-002	7297346*PED	2024-05-29	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-002	7132570*PED	2024-06-18	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-003	7297346*PED	2024-05-29	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-003	7132570*PED	2024-06-18	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-004	7297346*PED	2024-05-29	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-004	7132570*PED	2024-06-18	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-005	7297346*PED	2024-05-29	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-005	7132570*PED	2024-06-18	Pediatric extension	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-001	7297346*PED	2024-05-29	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-001	7132570*PED	2024-06-18	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-002	7297346*PED	2024-05-29	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-002	7132570*PED	2024-06-18	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-003	7297346*PED	2024-05-29	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-003	7132570*PED	2024-06-18	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-004	7297346*PED	2024-05-29	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-004	7132570*PED	2024-06-18	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-005	7297346*PED	2024-05-29	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-005	7132570*PED	2024-06-18	Pediatric extension	`d8e5a09893c0…`

Additional Listing Data#

Finished product: No
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ARMODAFINIL	250 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf31ebd7-fd9d-472c-88e1-94944f023ec0	Product name	3	20190628

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63459-225-07	Nuvigil	7 in 1 BLISTER PACK	TABLET	7	32
63459-225-30	Nuvigil	30 in 1 BOTTLE	TABLET	30	32
63459-225-35	Nuvigil	5 in 1 CARTON	TABLET	5	32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63459-225-30	EA - Each	63459-225	237e3089-bdcf-444a-8422-a268d8abfa40	1	2012-07-24
63459-225-60	EA - Each	63459-225	2259ae96-4c72-446f-9796-ecac197c58c3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ARMODAFINIL	ACTIVE INGREDIENT	V63XWA605I	NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]	16
ARMODAFINIL	ACTIVE MOIETY	V63XWA605I	NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]	16
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]	16
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]	16
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]	16
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]	16
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]	16
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]	16
ARMODAFINIL	ACTIVE INGREDIENT	V63XWA605I	NUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]	2
ARMODAFINIL	ACTIVE MOIETY	V63XWA605I	NUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63459-225	NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, LLC]	32	Current NDC, Legacy NDC, 3 package rows	20250507_d878aed0-ddbf-8fa1-abf7-d3e480260845.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nuvigil	ARMODAFINIL	Golden State Medical Supply, Inc.	3dd49302-f757-d945-e063-6294a90afcba	2025-09-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021875 application number: NDA021875
Nuvigil	ARMODAFINIL	Apotex Corp.	a69631d0-1263-769e-b232-4ab9160e0fa3	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021875 application number: NDA021875
ARMODAFINIL	ARMODAFINIL	DirectRx	ddd06dab-0855-5b4e-e053-2a95a90a5e67	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021875 application number: NDA021875
ARMODAFINIL	ARMODAFINIL	direct rx	b1ba1cdd-cf57-7a8c-e053-2a95a90a2c19	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021875 application number: NDA021875
Armodafinil	ARMODAFINIL	Quality Care Products LLC	98338994-7818-4b86-ae98-cd08fa700879	2024-12-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021875 application number: NDA021875
Armodafinil	ARMODAFINIL	Teva Pharmaceuticals USA, Inc.	b3cac300-c3d2-4189-a410-2aaf3773c090	2023-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021875 application number: NDA021875
Armodafinil	ARMODAFINIL	Sandoz Inc	a3341ec8-1ad4-49e2-922b-13d1b30c8c1d	2023-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021875 application number: NDA021875
Nuvigil	ARMODAFINIL	Cephalon, LLC	d878aed0-ddbf-8fa1-abf7-d3e480260845	2022-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021875 application number: NDA021875 ndc (product): 63459-225

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V63XWA605I	ARMODAFINIL	112111-43-0	ARMODAFINIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
724859	armodafinil 150 MG Oral Tablet	PSN	d878aed0-ddbf-8fa1-abf7-d3e480260845	32
861960	armodafinil 200 MG Oral Tablet	PSN	d878aed0-ddbf-8fa1-abf7-d3e480260845	32
724861	armodafinil 250 MG Oral Tablet	PSN	d878aed0-ddbf-8fa1-abf7-d3e480260845	32
724863	armodafinil 50 MG Oral Tablet	PSN	d878aed0-ddbf-8fa1-abf7-d3e480260845	32
805659	Nuvigil 150 MG Oral Tablet	PSN	d878aed0-ddbf-8fa1-abf7-d3e480260845	32
861962	Nuvigil 200 MG Oral Tablet	PSN	d878aed0-ddbf-8fa1-abf7-d3e480260845	32
805661	NUVIGIL 250 MG Oral Tablet	PSN	d878aed0-ddbf-8fa1-abf7-d3e480260845	32
805663	NUVIGIL 50 MG Oral Tablet	PSN	d878aed0-ddbf-8fa1-abf7-d3e480260845	32
805659	armodafinil 150 MG Oral Tablet [Nuvigil]	SBD	d878aed0-ddbf-8fa1-abf7-d3e480260845	32
861962	armodafinil 200 MG Oral Tablet [Nuvigil]	SBD	d878aed0-ddbf-8fa1-abf7-d3e480260845	32
805661	armodafinil 250 MG Oral Tablet [Nuvigil]	SBD	d878aed0-ddbf-8fa1-abf7-d3e480260845	32
805663	armodafinil 50 MG Oral Tablet [Nuvigil]	SBD	d878aed0-ddbf-8fa1-abf7-d3e480260845	32
724859	armodafinil 150 MG Oral Tablet	SCD	d878aed0-ddbf-8fa1-abf7-d3e480260845	32
861960	armodafinil 200 MG Oral Tablet	SCD	d878aed0-ddbf-8fa1-abf7-d3e480260845	32
724861	armodafinil 250 MG Oral Tablet	SCD	d878aed0-ddbf-8fa1-abf7-d3e480260845	32
724863	armodafinil 50 MG Oral Tablet	SCD	d878aed0-ddbf-8fa1-abf7-d3e480260845	32
805659	Nuvigil 150 MG Oral Tablet	SY	d878aed0-ddbf-8fa1-abf7-d3e480260845	32
861962	Nuvigil 200 MG Oral Tablet	SY	d878aed0-ddbf-8fa1-abf7-d3e480260845	32
805661	Nuvigil 250 MG Oral Tablet	SY	d878aed0-ddbf-8fa1-abf7-d3e480260845	32
805663	Nuvigil 50 MG Oral Tablet	SY	d878aed0-ddbf-8fa1-abf7-d3e480260845	32
724859	armodafinil 150 MG Oral Tablet	PSN	795a7ba3-c60b-4637-aa99-06c1e10af8a7	2
724861	armodafinil 250 MG Oral Tablet	PSN	795a7ba3-c60b-4637-aa99-06c1e10af8a7	2
805659	Nuvigil 150 MG Oral Tablet	PSN	795a7ba3-c60b-4637-aa99-06c1e10af8a7	2
805661	NUVIGIL 250 MG Oral Tablet	PSN	795a7ba3-c60b-4637-aa99-06c1e10af8a7	2
805659	armodafinil 150 MG Oral Tablet [Nuvigil]	SBD	795a7ba3-c60b-4637-aa99-06c1e10af8a7	2
805661	armodafinil 250 MG Oral Tablet [Nuvigil]	SBD	795a7ba3-c60b-4637-aa99-06c1e10af8a7	2
724859	armodafinil 150 MG Oral Tablet	SCD	795a7ba3-c60b-4637-aa99-06c1e10af8a7	2
724861	armodafinil 250 MG Oral Tablet	SCD	795a7ba3-c60b-4637-aa99-06c1e10af8a7	2
805659	Nuvigil 150 MG Oral Tablet	SY	795a7ba3-c60b-4637-aa99-06c1e10af8a7	2
805661	Nuvigil 250 MG Oral Tablet	SY	795a7ba3-c60b-4637-aa99-06c1e10af8a7	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63459-225-07	63459022507	7 in 1 BLISTER PACK						Historical
63459-225-30	63459022530	30 TABLET in 1 BOTTLE (63459-225-30)	30 tablet	2011-01-03	2026-06-30	No	No	Current
63459-225-35	63459022535	5 BLISTER PACK in 1 CARTON (63459-225-35) > 7 TABLET in 1 BLISTER PACK (63459-225-07)	5 blister pack	2009-05-26	0000-00-00	No	No	Current
63459-225-99	63459022599	16000 TABLET in 1 DRUM (63459-225-99)	16000 tablet	26-MAY-09				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nuvigil	Cephalon, LLC	2022-12-31	HUMAN PRESCRIPTION DRUG LABEL	32
NUVIGIL ® (armodafinil) Tablets [C-IV]	STAT Rx USA LLC \| PSS World Medical Inc.	2012-10-08	HUMAN PRESCRIPTION DRUG LABEL	2