Nuvigil
- Product NDC
- 35356-589
- 11-digit product format
- 353560589
- Labeler code
- 35356
- Product ID
- 35356-589_5270f354-e5f6-4e9b-824b-e3b4f92178a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- armodafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- NDA021875
- Marketing category
- NDA
- Marketing start
- 2009-06-01
- Marketing end
- 0000-00-00
- Substance
- ARMODAFINIL
- Active strength
- 150 mg/1
- DEA schedule
- CIV
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 | 35356-589 | D | Discontinued by firm | 2026-08-07 | ||
| excluded package | package | 35356-589 | 35356-589-30 | D | Discontinued by firm | 2026-08-07 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 35356-589-30 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 35356-589-30 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 35356-589-30 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 35356-589-30 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 35356-589-30 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 35356-589-30 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 35356-589-30 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 35356-589-30 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 35356-589-30 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 35356-589-30 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 35356-589-30 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 35356-589-30 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 35356-589-30 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021875-001 | NUVIGIL | 50MG | TABLET / ORAL | AB | RLD | 2007-06-15 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | 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 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021875-003 | NUVIGIL | 150MG | TABLET / ORAL | AB | RLD | 2007-06-15 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021875-004 | NUVIGIL | 250MG | TABLET / ORAL | AB | RLD, RS | 2007-06-15 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021875-005 | NUVIGIL | 200MG | TABLET / ORAL | AB | RLD | 2009-03-26 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2024-10-29 15:01 UTC | 2024-10 | N021875-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021875-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021875-004 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021875-005 | AB | 1 | d06236e962d9… |
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 |
|---|---|---|---|---|---|
| 35356-589-30 | EA - Each | 35356-589 | 735ef907-997d-42fd-b62f-850d21462fba | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
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 |