Armodafinil

Product NDC: 68788-7593
Requested package NDC: 68788-7593-3
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-7593	68788-7593-3	D	Discontinued by firm		2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A206069-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206069-002	ARMODAFINIL	150MG	TABLET / ORAL	AB	2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206069-003	ARMODAFINIL	250MG	TABLET / ORAL	AB	2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206069-004	ARMODAFINIL	200MG	TABLET / ORAL	AB	2018-12-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A206069-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206069-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206069-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206069-004	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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