Armodafinil

Product NDC: 68788-7593
11-digit product format: 687887593
Labeler code: 68788
Product ID: 68788-7593_77fff6b2-e2d2-4a19-ac32-47a749fc2738
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Armodafinil
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA206069
Marketing category: ANDA
Marketing start: 2020-02-14
Marketing end: 0000-00-00
Substance: ARMODAFINIL
Active strength: 250 mg/1
DEA schedule: CIV
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	68788-7593		D	Discontinued by firm	2026-08-17
excluded package	package	68788-7593	68788-7593-3	D	Discontinued by firm	2026-08-17
excluded package	package	68788-7593	68788-7593-6	D	Discontinued by firm	2026-08-17
excluded package	package	68788-7593	68788-7593-9	D	Discontinued by firm	2026-08-17

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7593-3	EA - Each	68788-7593	7a25a694-91c1-484e-9b55-704b9b8e9d3c	1	2022-11-07
68788-7593-6	EA - Each	68788-7593	1379c0d1-0b79-423f-8709-bb30f218d43d	1	2020-04-20
68788-7593-9	EA - Each	68788-7593	db81473e-8415-4d67-af9e-8d7eecf4603e	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7593	ARMODAFINIL TABLET [PREFERRED PHARMACEUTICALS INC.]	5	Legacy NDC	20240308_f9a9d842-1ed5-4da3-81ae-d2e21aebfd94.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 · 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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7593-3	68788759303	30 TABLET in 1 BOTTLE (68788-7593-3)	30 tablet	2020-02-14	0000-00-00	No	No	Current
68788-7593-6	68788759306	60 TABLET in 1 BOTTLE (68788-7593-6)	60 tablet	2020-02-14	0000-00-00	No	No	Current
68788-7593-9	68788759309	90 TABLET in 1 BOTTLE (68788-7593-9)	90 tablet	2020-02-14	0000-00-00	No	No	Current