Armodafinil

Product NDC: 72189-464
11-digit product format: 721890464
Labeler code: 72189
Product ID: 72189-464_2c4dd8aa-05cd-69f7-e063-6294a90abcd1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Armodafinil
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA206069
Marketing category: ANDA
Marketing start: 2023-05-03
Substance: ARMODAFINIL
Active strength: 50 mg/1
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 4 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
2025-01-20 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	72189-464-30	`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	72189-464-30	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Armodafinil
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ARMODAFINIL	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V63XWA605I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
724863	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
facd329b-1925-61df-e053-6294a90ab738	Available on FDA.report

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	Strength	SPL version
72189-464-30	Armodafinil	30 in 1 BOTTLE	TABLET	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-464-30	EA - Each	72189-464	5c8cfd16-8a8a-4f79-a0f5-0493b662570e	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-464	ARMODAFINIL TABLET [DIRECT_RX]	2	Current NDC, 1 package rows	20250123_facd329b-1925-61df-e053-6294a90ab738.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 ndc (product): 72189-464
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
724863	armodafinil 50 MG Oral Tablet	PSN	facd329b-1925-61df-e053-6294a90ab738	2
724863	armodafinil 50 MG Oral Tablet	SCD	facd329b-1925-61df-e053-6294a90ab738	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72189-464-30	72189046430	30 TABLET in 1 BOTTLE (72189-464-30)	30 tablet	2023-05-03	No	No	Current