Home DailyMed 8a40fc5d-dccb-4f5a-965c-8c336cf1497c National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:12:29 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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2007-06-15 N021875-002 NUVIGIL ARMODAFINIL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-03-26 N021875-003 NUVIGIL ARMODAFINIL 150MG TABLET / ORAL AB RLD 2007-06-15 N021875-004 NUVIGIL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.
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 · 215 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 2026-09-14 22:38:34 2026-08 N021875-001 NUVIGIL 50MG TABLET / ORAL AB RLD 2007-06-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021875-003 NUVIGIL 150MG TABLET / ORAL AB RLD 2007-06-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021875-004 NUVIGIL 250MG TABLET / ORAL AB RLD, RS 2007-06-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021875-005 NUVIGIL 200MG TABLET / ORAL AB RLD 2009-03-26 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
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 Use code Coverage / status Submission date 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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.