Home NDC 55253-801 Modafinil
Product NDC 55253-801
11-digit product format 552530801
Labeler code 55253
Product ID 55253-801_428b6de2-f791-43db-a186-d19312a348fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Modafinil
Dosage form TABLET
Route ORAL
Labeler CIMA LABS INC.
Application NDA020717
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2012-03-29
Marketing end 2027-03-31
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
Current FDA listing Yes 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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table 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…
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.
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.
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 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…
Additional Listing Data#
Finished product Yes
Brand name base Modafinil 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 205324 Internal RxNorm lookup 260218 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55253-801-30 Modafinil 30 in 1 BOTTLE TABLET 30 20 55253-801-90 Modafinil 90 in 1 BOTTLE TABLET 90 20
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55253-801 MODAFINIL TABLET [CIMA LABS INC.] 20 Current NDC, Legacy NDC, 2 package rows 20240229_9f3b0bd2-72a3-411f-aeec-b533373f1a97.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.
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 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 ndc (product): 55253-801 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55253-801-30 55253080130 30 TABLET in 1 BOTTLE (55253-801-30) 30 tablet 2012-03-29 2027-03-31 No No Current 55253-801-90 55253080190 90 TABLET in 1 BOTTLE (55253-801-90) 90 tablet 2012-03-29 0000-00-00 No No Current