Armodafinil
- Product NDC
- 71335-1842
- 11-digit product format
- 713351842
- Labeler code
- 71335
- Product ID
- 71335-1842_c72537e1-e75d-487d-abdd-aae585da7778
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Armodafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- NDA021875
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2016-12-01
- Marketing end
- 0000-00-00
- Substance
- ARMODAFINIL
- Active strength
- 250 mg/1
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 71335-1842 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 71335-1842 | 71335-1842-1 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 71335-1842 | 71335-1842-2 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 71335-1842 | 71335-1842-3 | D | Discontinued by firm | 2026-08-17 |
Orange Book products#
| 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| N021875-002 | NUVIGIL | ARMODAFINIL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2009-03-26 | |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#
| 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.
| 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#
| 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#
| 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… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71335-1842-1 | EA - Each | 71335-1842 | b97ab772-c6ca-4fc8-809b-85c9911183e3 | 1 | 2023-04-07 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71335-1842 | ARMODAFINIL TABLET [BRYANT RANCH PREPACK] | 102 | Legacy NDC | 20231116_b6e25369-0dbf-4e96-b124-87bd577af22e.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.
| 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 | 021875 NDA021875 |
| Nuvigil | ARMODAFINIL | Apotex Corp. | a69631d0-1263-769e-b232-4ab9160e0fa3 | 2025-08-18 | Warnings, Adverse reactions | 021875 NDA021875 |
| ARMODAFINIL | ARMODAFINIL | DirectRx | ddd06dab-0855-5b4e-e053-2a95a90a5e67 | 2025-01-22 | Warnings, Adverse reactions | 021875 NDA021875 |
| ARMODAFINIL | ARMODAFINIL | direct rx | b1ba1cdd-cf57-7a8c-e053-2a95a90a2c19 | 2025-01-20 | Warnings, Adverse reactions | 021875 NDA021875 |
| Armodafinil | ARMODAFINIL | Quality Care Products LLC | 98338994-7818-4b86-ae98-cd08fa700879 | 2024-12-17 | Warnings, Adverse reactions | 021875 NDA021875 |
| Armodafinil | ARMODAFINIL | Teva Pharmaceuticals USA, Inc. | b3cac300-c3d2-4189-a410-2aaf3773c090 | 2023-01-31 | Warnings, Adverse reactions | 021875 NDA021875 |
| Armodafinil | ARMODAFINIL | Sandoz Inc | a3341ec8-1ad4-49e2-922b-13d1b30c8c1d | 2023-01-31 | Warnings, Adverse reactions | 021875 NDA021875 |
| Nuvigil | ARMODAFINIL | Cephalon, LLC | d878aed0-ddbf-8fa1-abf7-d3e480260845 | 2022-12-31 | Warnings, Adverse reactions | 021875 NDA021875 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71335-1842-1 | 71335184201 | 30 TABLET in 1 BOTTLE (71335-1842-1) | 30 tablet | 2021-04-29 | 0000-00-00 | No | No | Current |
| 71335-1842-2 | 71335184202 | 28 TABLET in 1 BOTTLE (71335-1842-2) | 28 tablet | 2021-04-29 | 0000-00-00 | No | No | Current |
| 71335-1842-3 | 71335184203 | 90 TABLET in 1 BOTTLE (71335-1842-3) | 90 tablet | 2021-04-29 | 0000-00-00 | No | No | Current |