Home DailyMed cb0ea318-ed28-45fe-bd13-515f3baaa04f 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 02:41:02 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2007-06-15 N021875-002 NUVIGIL ARMODAFINIL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-03-26 N021875-003 NUVIGIL ARMODAFINIL 150MG TABLET / ORAL AB RLD 2007-06-15 N021875-004 NUVIGIL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…
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 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.