Provigil

Product NDC: 60505-4851
Requested package NDC: 60505-4851-7
11-digit product format: 605054851
Labeler code: 60505
Product ID: 60505-4851_ff96d3ff-6a1c-2545-b939-f383e0262179
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Modafinil
Dosage form: TABLET
Route: ORAL
Labeler: Apotex Corp
Application: NDA020717
Marketing category: NDA
Marketing start: 2025-08-31
Substance: MODAFINIL
Active strength: 100 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: 2026-12-31
Current FDA listing: Yes

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.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	60505-4851	60505-4851-7	UNFINISHED	Active or certified unfinished drug listing		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.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	60505-4851	60505-4851-7	UNFINISHED	Active or certified unfinished drug listing		unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	60505-4851	60505-4851-7	UNFINISHED	Active or certified unfinished drug listing		unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
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#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
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.

Product history page 1 of 3 · 82 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
2026-02-19 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#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
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#

Patent history page 1 of 3 · 118 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Provigil
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MODAFINIL	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R3UK8X3U3D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
205324	Internal RxNorm lookup
213471	Internal RxNorm lookup
226426	Internal RxNorm lookup
260218	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0391f182-1958-9fef-a944-53b229ce99e7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
91b7dea8-da1b-abb1-9750-2e680cd894b6	Product name	2	20171005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60505-4851-3	Provigil	30 in 1 BOTTLE	TABLET	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-4851-3	EA - Each	60505-4851	901f6c28-9202-4a4c-ae1a-4d916dd83c36	1	2025-09-12

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 · 5 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (NDA): 020717 application number: NDA020717
Provigil	MODAFINIL	Apotex Corp	0391f182-1958-9fef-a944-53b229ce99e7	2025-08-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020717 application number: NDA020717 ndc (product): 60505-4851
Modafinil	MODAFINIL	CIMA LABS INC.	9f3b0bd2-72a3-411f-aeec-b533373f1a97	2023-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020717 application number: NDA020717
Provigil	MODAFINIL	Cephalon, LLC	e16c26ad-7bc2-d155-3a5d-da83ad6492c8	2022-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020717 application number: NDA020717
modafinil	MODAFINIL	Aphena Pharma Solutions - Tennessee, LLC	cad4201c-133c-4a61-9d93-3c5e51695430	2017-12-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020717 application number: NDA020717

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R3UK8X3U3D	MODAFINIL	68693-11-8	MODAFINIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
260218	modafinil 100 MG Oral Tablet	PSN	0391f182-1958-9fef-a944-53b229ce99e7	4
205324	modafinil 200 MG Oral Tablet	PSN	0391f182-1958-9fef-a944-53b229ce99e7	4
226426	Provigil 100 MG Oral Tablet	PSN	0391f182-1958-9fef-a944-53b229ce99e7	4
213471	Provigil 200 MG Oral Tablet	PSN	0391f182-1958-9fef-a944-53b229ce99e7	4
226426	modafinil 100 MG Oral Tablet [Provigil]	SBD	0391f182-1958-9fef-a944-53b229ce99e7	4
213471	modafinil 200 MG Oral Tablet [Provigil]	SBD	0391f182-1958-9fef-a944-53b229ce99e7	4
260218	modafinil 100 MG Oral Tablet	SCD	0391f182-1958-9fef-a944-53b229ce99e7	4
205324	modafinil 200 MG Oral Tablet	SCD	0391f182-1958-9fef-a944-53b229ce99e7	4
226426	Provigil 100 MG Oral Tablet	SY	0391f182-1958-9fef-a944-53b229ce99e7	4
213471	Provigil 200 MG Oral Tablet	SY	0391f182-1958-9fef-a944-53b229ce99e7	4
260218	modafinil 100 MG Oral Tablet	PSN	3b8d1c32-dac9-50e6-e063-6394a90aa5a5	2
205324	modafinil 200 MG Oral Tablet	PSN	3b8d1c32-dac9-50e6-e063-6394a90aa5a5	2
226426	Provigil 100 MG Oral Tablet	PSN	3b8d1c32-dac9-50e6-e063-6394a90aa5a5	2
213471	Provigil 200 MG Oral Tablet	PSN	3b8d1c32-dac9-50e6-e063-6394a90aa5a5	2
226426	modafinil 100 MG Oral Tablet [Provigil]	SBD	3b8d1c32-dac9-50e6-e063-6394a90aa5a5	2
213471	modafinil 200 MG Oral Tablet [Provigil]	SBD	3b8d1c32-dac9-50e6-e063-6394a90aa5a5	2
260218	modafinil 100 MG Oral Tablet	SCD	3b8d1c32-dac9-50e6-e063-6394a90aa5a5	2
205324	modafinil 200 MG Oral Tablet	SCD	3b8d1c32-dac9-50e6-e063-6394a90aa5a5	2
226426	Provigil 100 MG Oral Tablet	SY	3b8d1c32-dac9-50e6-e063-6394a90aa5a5	2
213471	Provigil 200 MG Oral Tablet	SY	3b8d1c32-dac9-50e6-e063-6394a90aa5a5	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
60505-4851-7	60505485107	32000 TABLET in 1 PAIL (60505-4851-7)	32000 tablet	20-MAY-25	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Provigil	Golden State Medical Supply, Inc.	2025-10-16	HUMAN PRESCRIPTION DRUG LABEL	2
Provigil	Apotex Corp	2025-08-27	HUMAN PRESCRIPTION DRUG LABEL	4