Provigil
- Product NDC
- 50436-0201
- Requested package NDC
- 50436-0201-1
- 11-digit product format
- 504360201
- Labeler code
- 50436
- Product ID
- 50436-0201_1e74e36c-9b6e-4d3b-8d7f-1bd56aab2a9a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- NDA020717
- Marketing category
- NDA
- Marketing start
- 1999-02-15
- Marketing end
- 0000-00-00
- Substance
- MODAFINIL
- Active strength
- 200 mg/1
- Pharmacologic classes
- Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]
- 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 package | package | 50436-0201 | 50436-0201-1 | 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020717-001 | PROVIGIL | MODAFINIL | 100MG | TABLET / ORAL | AB | RLD | 1998-12-24 |
| N020717-002 | PROVIGIL | MODAFINIL | 200MG | TABLET / ORAL | AB | RLD, RS | 1998-12-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020717-001 | AB |
| N020717-002 | 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 | N020717-001 | PROVIGIL | 100MG | TABLET / ORAL | AB | RLD | 1998-12-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020717-002 | PROVIGIL | 200MG | TABLET / ORAL | AB | RLD, RS | 1998-12-24 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020717-001 | PROVIGIL | 100MG | TABLET / ORAL | AB | RLD | 1998-12-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020717-002 | PROVIGIL | 200MG | TABLET / ORAL | AB | RLD, RS | 1998-12-24 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020717-001 | PROVIGIL | 100MG | TABLET / ORAL | AB | RLD | 1998-12-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020717-002 | PROVIGIL | 200MG | TABLET / ORAL | AB | RLD, RS | 1998-12-24 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020717-001 | PROVIGIL | 100MG | TABLET / ORAL | AB | RLD | 1998-12-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020717-002 | PROVIGIL | 200MG | TABLET / ORAL | AB | RLD, RS | 1998-12-24 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020717-001 | PROVIGIL | 100MG | TABLET / ORAL | AB | RLD | 1998-12-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020717-002 | PROVIGIL | 200MG | TABLET / ORAL | AB | RLD, RS | 1998-12-24 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020717-001 | PROVIGIL | 100MG | TABLET / ORAL | AB | RLD | 1998-12-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020717-002 | PROVIGIL | 200MG | TABLET / ORAL | AB | RLD, RS | 1998-12-24 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020717-001 | PROVIGIL | 100MG | TABLET / ORAL | AB | RLD | 1998-12-24 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020717-002 | PROVIGIL | 200MG | TABLET / ORAL | AB | RLD, RS | 1998-12-24 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020717-001 | PROVIGIL | 100MG | TABLET / ORAL | AB | RLD | 1998-12-24 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020717-002 | PROVIGIL | 200MG | TABLET / ORAL | AB | RLD, RS | 1998-12-24 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020717-001 | PROVIGIL | 100MG | TABLET / ORAL | AB | RLD | 1998-12-24 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020717-002 | PROVIGIL | 200MG | TABLET / ORAL | AB | RLD, RS | 1998-12-24 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020717-001 | PROVIGIL | 100MG | TABLET / ORAL | AB | RLD | 1998-12-24 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020717-002 | PROVIGIL | 200MG | TABLET / ORAL | AB | RLD, RS | 1998-12-24 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020717-001 | PROVIGIL | 100MG | TABLET / ORAL | AB | RLD | 1998-12-24 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020717-002 | PROVIGIL | 200MG | TABLET / ORAL | AB | RLD, RS | 1998-12-24 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020717-001 | PROVIGIL | 100MG | TABLET / ORAL | AB | RLD | 1998-12-24 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020717-002 | PROVIGIL | 200MG | TABLET / ORAL | AB | RLD, RS | 1998-12-24 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020717-001 | PROVIGIL | 100MG | TABLET / ORAL | AB | RLD | 1998-12-24 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020717-002 | PROVIGIL | 200MG | TABLET / ORAL | AB | RLD, RS | 1998-12-24 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N020717-001 | PROVIGIL | 100MG | TABLET / ORAL | AB | RLD | 1998-12-24 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N020717-002 | PROVIGIL | 200MG | TABLET / ORAL | AB | RLD, RS | 1998-12-24 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020717-001 | PROVIGIL | 100MG | TABLET / ORAL | AB | RLD | 1998-12-24 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020717-002 | PROVIGIL | 200MG | TABLET / ORAL | AB | RLD, RS | 1998-12-24 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020717-001 | PROVIGIL | 100MG | TABLET / ORAL | AB | RLD | 1998-12-24 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020717-002 | PROVIGIL | 200MG | TABLET / ORAL | AB | RLD, RS | 1998-12-24 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020717-001 | PROVIGIL | 100MG | TABLET / ORAL | AB | RLD | 1998-12-24 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020717-002 | PROVIGIL | 200MG | TABLET / ORAL | AB | RLD, RS | 1998-12-24 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020717-001 | PROVIGIL | 100MG | TABLET / ORAL | AB | RLD | 1998-12-24 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020717-002 | PROVIGIL | 200MG | TABLET / ORAL | AB | RLD, RS | 1998-12-24 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020717-001 | PROVIGIL | 100MG | TABLET / ORAL | AB | RLD | 1998-12-24 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020717-002 | PROVIGIL | 200MG | TABLET / ORAL | AB | RLD, RS | 1998-12-24 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020717-001 | PROVIGIL | 100MG | TABLET / ORAL | AB | RLD | 1998-12-24 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020717-002 | PROVIGIL | 200MG | TABLET / ORAL | AB | RLD, RS | 1998-12-24 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020717-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020717-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020717-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020717-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020717-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020717-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020717-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020717-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020717-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020717-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020717-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020717-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020717-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020717-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020717-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020717-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020717-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020717-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020717-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020717-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020717-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020717-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020717-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020717-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020717-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020717-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N020717-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N020717-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020717-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020717-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020717-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020717-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020717-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020717-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020717-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020717-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020717-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020717-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020717-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020717-002 | AB | 1 | 782e0a99824c… |
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 | N020717-001 | 7297346*PED | 2024-05-29 | Pediatric extension | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020717-002 | 7297346*PED | 2024-05-29 | Pediatric extension | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020717-001 | 7297346*PED | 2024-05-29 | Pediatric extension | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020717-002 | 7297346*PED | 2024-05-29 | Pediatric extension | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020717-001 | 7297346*PED | 2024-05-29 | Pediatric extension | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020717-002 | 7297346*PED | 2024-05-29 | Pediatric extension | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020717-001 | 7297346*PED | 2024-05-29 | Pediatric extension | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020717-002 | 7297346*PED | 2024-05-29 | Pediatric extension | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020717-001 | 7297346*PED | 2024-05-29 | Pediatric extension | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020717-002 | 7297346*PED | 2024-05-29 | Pediatric extension | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020717-001 | 7297346*PED | 2024-05-29 | Pediatric extension | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020717-002 | 7297346*PED | 2024-05-29 | Pediatric extension | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020717-001 | 7297346*PED | 2024-05-29 | Pediatric extension | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020717-002 | 7297346*PED | 2024-05-29 | Pediatric extension | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020717-001 | 7297346*PED | 2024-05-29 | Pediatric extension | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020717-002 | 7297346*PED | 2024-05-29 | Pediatric extension | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N020717-001 | 7297346*PED | 2024-05-29 | Pediatric extension | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N020717-002 | 7297346*PED | 2024-05-29 | Pediatric extension | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020717-001 | 7297346 | 2023-11-29 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020717-001 | 7297346*PED | 2024-05-29 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020717-002 | 7297346 | 2023-11-29 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020717-002 | 7297346*PED | 2024-05-29 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020717-001 | 7297346 | 2023-11-29 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020717-001 | 7297346*PED | 2024-05-29 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020717-002 | 7297346 | 2023-11-29 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020717-002 | 7297346*PED | 2024-05-29 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020717-001 | 7297346 | 2023-11-29 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020717-001 | 7297346*PED | 2024-05-29 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020717-002 | 7297346 | 2023-11-29 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020717-002 | 7297346*PED | 2024-05-29 | Pediatric extension | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020717-001 | 7297346 | 2023-11-29 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020717-001 | 7297346*PED | 2024-05-29 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020717-002 | 7297346 | 2023-11-29 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020717-002 | 7297346*PED | 2024-05-29 | Pediatric extension | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N020717-001 | 7297346 | 2023-11-29 | Drug product | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N020717-001 | 7297346*PED | 2024-05-29 | Pediatric extension | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N020717-002 | 7297346 | 2023-11-29 | Drug product | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N020717-002 | 7297346*PED | 2024-05-29 | Pediatric extension | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020717-001 | 7297346 | 2023-11-29 | Drug product | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020717-001 | 7297346*PED | 2024-05-29 | Pediatric extension | 782e0a99824c… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-0201-1 | EA - Each | 50436-0201 | 1619b57a-6b35-42ed-8445-f0588606aeed | 1 | 2012-07-24 |
| 50436-0201-2 | EA - Each | 50436-0201 | 17d9fbc4-c09b-4c36-ab42-eb1679edf607 | 1 | 2021-12-08 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| modafinil | ACTIVE INGREDIENT | R3UK8X3U3D | PROVIGIL (MODAFINIL) TABLET [UNIT DOSE SERVICES] | 2 | |
| modafinil | ACTIVE MOIETY | R3UK8X3U3D | PROVIGIL (MODAFINIL) TABLET [UNIT DOSE SERVICES] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PROVIGIL (MODAFINIL) TABLET [UNIT DOSE SERVICES] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | PROVIGIL (MODAFINIL) TABLET [UNIT DOSE SERVICES] | 2 | |
| lactose | INACTIVE INGREDIENT | J2B2A4N98G | PROVIGIL (MODAFINIL) TABLET [UNIT DOSE SERVICES] | 2 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | PROVIGIL (MODAFINIL) TABLET [UNIT DOSE SERVICES] | 2 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | PROVIGIL (MODAFINIL) TABLET [UNIT DOSE SERVICES] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | PROVIGIL (MODAFINIL) TABLET [UNIT DOSE SERVICES] | 2 |
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 |
|---|---|---|---|---|---|---|
| Provigil | MODAFINIL | Golden State Medical Supply, Inc. | 3b8d1c32-dac9-50e6-e063-6394a90aa5a5 | 2025-10-16 | Warnings, Adverse reactions | 020717 NDA020717 |
| Provigil | MODAFINIL | Apotex Corp | 0391f182-1958-9fef-a944-53b229ce99e7 | 2025-08-27 | Warnings, Adverse reactions | 020717 NDA020717 |
| Modafinil | MODAFINIL | CIMA LABS INC. | 9f3b0bd2-72a3-411f-aeec-b533373f1a97 | 2023-01-31 | Warnings, Adverse reactions | 020717 NDA020717 |
| Provigil | MODAFINIL | Cephalon, LLC | e16c26ad-7bc2-d155-3a5d-da83ad6492c8 | 2022-12-31 | Warnings, Adverse reactions | 020717 NDA020717 |
| modafinil | MODAFINIL | Aphena Pharma Solutions - Tennessee, LLC | cad4201c-133c-4a61-9d93-3c5e51695430 | 2017-12-19 | Warnings, Adverse reactions | 020717 NDA020717 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50436-0201-1 | 50436020101 | 30 TABLET in 1 BOTTLE (50436-0201-1) | 30 tablet | 1999-02-15 | 0000-00-00 | No | No | Current |