Modafinil

Product NDC
43353-831
11-digit product format
433530831
Labeler code
43353
Product ID
43353-831_adec9b98-1867-41a0-9288-3185c095a6fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
modafinil
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076594
Marketing category
ANDA
Marketing start
2012-08-10
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
2019-12-31
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.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43353-831IInactivated by FDA2026-08-07
excluded packagepackage43353-83143353-831-30IInactivated by FDA2026-08-07
excluded packagepackage43353-83143353-831-53IInactivated by FDA2026-08-07

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 2 · 63 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-831-53d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-831-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-831-53f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-831-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43353-831-532ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43353-831-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43353-831-53a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43353-831-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43353-831-53cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43353-831-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43353-831-53cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43353-831-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43353-831-53302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43353-831-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43353-831-53ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43353-831-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43353-831-530efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43353-831-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43353-831-53ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43353-831-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43353-831-53367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43353-831-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43353-831-53557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43353-831-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43353-831-538af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43353-831-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43353-831-53834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43353-831-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43353-831-531332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43353-831-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage43353-831-53fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage43353-831-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage43353-831-5386f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage43353-831-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage43353-831-53bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage43353-831-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage43353-831-538dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage43353-831-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage43353-831-53e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage43353-831-30e2bbac7714bc…27bdfed8d636…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076594-001MODAFINILMODAFINIL100MGTABLET / ORAL2012-07-16
A076594-002MODAFINILMODAFINIL200MGTABLET / ORAL2012-07-16

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076594-001MODAFINIL100MGTABLET / ORAL2012-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076594-002MODAFINIL200MGTABLET / ORAL2012-07-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076594-001MODAFINIL100MGTABLET / ORAL2012-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076594-002MODAFINIL200MGTABLET / ORAL2012-07-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076594-001MODAFINIL100MGTABLET / ORAL2012-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076594-002MODAFINIL200MGTABLET / ORAL2012-07-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076594-001MODAFINIL100MGTABLET / ORAL2012-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076594-002MODAFINIL200MGTABLET / ORAL2012-07-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076594-001MODAFINIL100MGTABLET / ORAL2012-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076594-002MODAFINIL200MGTABLET / ORAL2012-07-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076594-001MODAFINIL100MGTABLET / ORAL2012-07-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076594-002MODAFINIL200MGTABLET / ORAL2012-07-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076594-001MODAFINIL100MGTABLET / ORAL2012-07-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076594-002MODAFINIL200MGTABLET / ORAL2012-07-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076594-001MODAFINIL100MGTABLET / ORAL2012-07-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076594-002MODAFINIL200MGTABLET / ORAL2012-07-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076594-001MODAFINIL100MGTABLET / ORAL2012-07-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076594-002MODAFINIL200MGTABLET / ORAL2012-07-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076594-001MODAFINIL100MGTABLET / ORAL2012-07-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A076594-002MODAFINIL200MGTABLET / ORAL2012-07-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076594-001MODAFINIL100MGTABLET / ORAL2012-07-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076594-002MODAFINIL200MGTABLET / ORAL2012-07-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076594-001MODAFINIL100MGTABLET / ORAL2012-07-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076594-002MODAFINIL200MGTABLET / ORAL2012-07-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076594-001MODAFINIL100MGTABLET / ORAL2012-07-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076594-002MODAFINIL200MGTABLET / ORAL2012-07-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076594-001MODAFINIL100MGTABLET / ORAL2012-07-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076594-002MODAFINIL200MGTABLET / ORAL2012-07-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076594-001MODAFINIL100MGTABLET / ORAL2012-07-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076594-002MODAFINIL200MGTABLET / ORAL2012-07-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076594-001MODAFINIL100MGTABLET / ORAL2012-07-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076594-002MODAFINIL200MGTABLET / ORAL2012-07-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076594-001MODAFINIL100MGTABLET / ORAL2012-07-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076594-002MODAFINIL200MGTABLET / ORAL2012-07-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076594-001MODAFINIL100MGTABLET / ORALAB2012-07-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076594-002MODAFINIL200MGTABLET / ORALAB2012-07-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076594-001MODAFINIL100MGTABLET / ORAL2012-07-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076594-002MODAFINIL200MGTABLET / ORAL2012-07-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076594-001MODAFINIL100MGTABLET / ORAL2012-07-16782e0a99824c…
2021-12-28 21:50 UTC2021-12A076594-002MODAFINIL200MGTABLET / ORAL2012-07-16782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076594-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076594-002AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076594-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076594-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076594-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A076594-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076594-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A076594-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076594-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076594-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076594-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076594-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076594-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076594-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076594-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076594-002AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
91b7dea8-da1b-abb1-9750-2e680cd894b6Product name220171005

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-831-302020-01-31C16284748780-19d75b9d0-7b94-f424-e053-dadaa90a57ce514d242d-48c9-4162-a85a-a433b41107ac
43353-831-532020-01-31C16284748780-19d75b9d0-7b94-f424-e053-dadaa90a57ce514d242d-48c9-4162-a85a-a433b41107ac

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-831-30Modafinil30 in 1 BOTTLE, PLASTICTABLET301
43353-831-53Modafinil60 in 1 BOTTLE, PLASTICTABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-831-30EA - Each43353-831974e9dfe-72db-4aa8-9658-b3519fe48dfd12014-05-02
43353-831-53EA - Each43353-831ab11c3db-bdc0-4133-8113-f0e592ee2e7312014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MODAFINILACTIVE INGREDIENTR3UK8X3U3DMODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MODAFINILACTIVE MOIETYR3UK8X3U3DMODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JMODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EMODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-831MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 2 package rows20140415_514d242d-48c9-4162-a85a-a433b41107ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205324modafinil 200 MG Oral TabletPSN514d242d-48c9-4162-a85a-a433b41107ac1
205324modafinil 200 MG Oral TabletSCD514d242d-48c9-4162-a85a-a433b41107ac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-831-304335308313030 in 1 BOTTLE, PLASTICHistorical
43353-831-534335308315360 in 1 BOTTLE, PLASTICHistorical