Armodafinil

Product NDC: 0781-8037
11-digit product format: 007818037
Labeler code: 0781
Product ID: 0781-8037_dea0ad34-a35f-42ba-a6b6-dea58a16868f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Armodafinil
Dosage form: TABLET
Route: ORAL
Labeler: Sandoz Inc
Application: NDA021875
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2016-12-01
Marketing end: 2028-06-30
Substance: ARMODAFINIL
Active strength: 150 mg/1
DEA schedule: CIV
NDC exclude flag: No
Current FDA listing: Yes

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N021875-002	NUVIGIL	ARMODAFINIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-03-26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N021875-002	NUVIGIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-03-26	`caaa826d4ba7…`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: Yes
Brand name base: Armodafinil

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ARMODAFINIL	150 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
724859	Internal RxNorm lookup
724861	Internal RxNorm lookup
724863	Internal RxNorm lookup
861960	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
a3341ec8-1ad4-49e2-922b-13d1b30c8c1d	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
0781-8037-31	Armodafinil	30 in 1 BOTTLE	TABLET	30		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-8037-31	EA - Each	0781-8037	3606a3cc-9baf-41a1-8243-54e270922925	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-8037	ARMODAFINIL TABLET [SANDOZ INC]	14	Current NDC, Legacy NDC, 1 package rows	20240828_a3341ec8-1ad4-49e2-922b-13d1b30c8c1d.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 ndc (product): 0781-8037
Nuvigil	ARMODAFINIL	Cephalon, LLC	d878aed0-ddbf-8fa1-abf7-d3e480260845	2022-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021875 application number: NDA021875

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	a3341ec8-1ad4-49e2-922b-13d1b30c8c1d	16
861960	armodafinil 200 MG Oral Tablet	PSN	a3341ec8-1ad4-49e2-922b-13d1b30c8c1d	16
724861	armodafinil 250 MG Oral Tablet	PSN	a3341ec8-1ad4-49e2-922b-13d1b30c8c1d	16
724863	armodafinil 50 MG Oral Tablet	PSN	a3341ec8-1ad4-49e2-922b-13d1b30c8c1d	16
724859	armodafinil 150 MG Oral Tablet	SCD	a3341ec8-1ad4-49e2-922b-13d1b30c8c1d	16
861960	armodafinil 200 MG Oral Tablet	SCD	a3341ec8-1ad4-49e2-922b-13d1b30c8c1d	16
724861	armodafinil 250 MG Oral Tablet	SCD	a3341ec8-1ad4-49e2-922b-13d1b30c8c1d	16
724863	armodafinil 50 MG Oral Tablet	SCD	a3341ec8-1ad4-49e2-922b-13d1b30c8c1d	16
724859	armodafinil 150 MG Oral Tablet	PSN	7ea5430a-df28-e521-e053-2a91aa0a8f22	2
724859	armodafinil 150 MG Oral Tablet	SCD	7ea5430a-df28-e521-e053-2a91aa0a8f22	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-8037-31	00781803731	30 TABLET in 1 BOTTLE (0781-8037-31)	30 tablet	2016-12-01	2028-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Armodafinil	Bryant Ranch Prepack	2023-11-17	HUMAN PRESCRIPTION DRUG LABEL	103
Armodafinil	Sandoz Inc \| Pliva Hrvatska d.o.o.	2023-01-31	HUMAN PRESCRIPTION DRUG LABEL	16
Armodafinil	Preferred Pharmacceuticals Inc.	2022-03-08	HUMAN PRESCRIPTION DRUG LABEL	3
Armodafinil	Direct_Rx	2019-04-03	HUMAN PRESCRIPTION DRUG LABEL	2