Evekeo ODT

Product NDC
24338-033
Requested package NDC
24338-033-01
11-digit product format
243380033
Labeler code
24338
Product ID
24338-033_84fe08cc-dddd-4ab6-9d7a-f62076b924e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMPHETAMINE SULFATE
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Azurity Pharmaceuticals, Inc.
Application
NDA209905
Marketing category
NDA
Marketing start
2019-06-28
Marketing end
0000-00-00
Substance
AMPHETAMINE SULFATE
Active strength
10 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage24338-03324338-033-01DDiscontinued by firm2026-08-07

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209905-001EVEKEO ODTAMPHETAMINE SULFATE5MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-30
N209905-002EVEKEO ODTAMPHETAMINE SULFATE10MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-30
N209905-003EVEKEO ODTAMPHETAMINE SULFATE15MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-30
N209905-004EVEKEO ODTAMPHETAMINE SULFATE20MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-30
N209905-005EVEKEO ODTAMPHETAMINE SULFATE2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2021-04-16

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209905-001104415542037-03-10Drug product2019-10-15
N209905-001111607722037-03-10Drug product2021-12-09
N209905-001118965622037-03-10U-32992024-02-16
N209905-002104415542037-03-10Drug product2019-10-15
N209905-002111607722037-03-10Drug product2021-12-09
N209905-002118965622037-03-10U-32992024-02-16
N209905-003104415542037-03-10Drug product2019-10-15
N209905-003111607722037-03-10Drug product2021-12-09
N209905-003118965622037-03-10U-32992024-02-16
N209905-004104415542037-03-10Drug product2019-10-15
N209905-004111607722037-03-10Drug product2021-12-09
N209905-004118965622037-03-10U-32992024-02-16
N209905-005104415542037-03-10Drug product2021-07-07
N209905-005111607722037-03-10Drug product2021-12-09

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 5 · 197 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N209905-001EVEKEO ODT5MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209905-002EVEKEO ODT10MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209905-003EVEKEO ODT15MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209905-004EVEKEO ODT20MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209905-005EVEKEO ODT2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2021-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209905-001EVEKEO ODT5MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209905-002EVEKEO ODT10MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209905-003EVEKEO ODT15MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209905-004EVEKEO ODT20MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209905-005EVEKEO ODT2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2021-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N209905-001EVEKEO ODT5MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209905-002EVEKEO ODT10MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209905-003EVEKEO ODT15MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209905-004EVEKEO ODT20MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209905-005EVEKEO ODT2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2021-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209905-001EVEKEO ODT5MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209905-002EVEKEO ODT10MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209905-003EVEKEO ODT15MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209905-004EVEKEO ODT20MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209905-005EVEKEO ODT2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2021-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209905-001EVEKEO ODT5MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209905-002EVEKEO ODT10MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209905-003EVEKEO ODT15MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209905-004EVEKEO ODT20MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209905-005EVEKEO ODT2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2021-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209905-001EVEKEO ODT5MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209905-002EVEKEO ODT10MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209905-003EVEKEO ODT15MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209905-004EVEKEO ODT20MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209905-005EVEKEO ODT2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2021-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209905-001EVEKEO ODT5MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209905-002EVEKEO ODT10MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209905-003EVEKEO ODT15MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209905-004EVEKEO ODT20MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209905-005EVEKEO ODT2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2021-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209905-001EVEKEO ODT5MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209905-002EVEKEO ODT10MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209905-003EVEKEO ODT15MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209905-004EVEKEO ODT20MGTABLET, ORALLY DISINTEGRATING / ORALRLD2019-01-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209905-005EVEKEO ODT2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2021-04-165bbf6a4d5a75…

Observed Orange Book patent history#

Patent history page 1 of 15 · 580 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N209905-001104415542037-03-10Drug product2019-10-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209905-001111607722037-03-10Drug product2021-12-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209905-001118965622037-03-10U-32992024-02-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209905-002104415542037-03-10Drug product2019-10-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209905-002111607722037-03-10Drug product2021-12-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209905-002118965622037-03-10U-32992024-02-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209905-003104415542037-03-10Drug product2019-10-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209905-003111607722037-03-10Drug product2021-12-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209905-003118965622037-03-10U-32992024-02-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209905-004104415542037-03-10Drug product2019-10-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209905-004111607722037-03-10Drug product2021-12-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209905-004118965622037-03-10U-32992024-02-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209905-005104415542037-03-10Drug product2021-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209905-005111607722037-03-10Drug product2021-12-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209905-001104415542037-03-10Drug product2019-10-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209905-001111607722037-03-10Drug product2021-12-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209905-001118965622037-03-10U-32992024-02-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209905-002104415542037-03-10Drug product2019-10-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209905-002111607722037-03-10Drug product2021-12-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209905-002118965622037-03-10U-32992024-02-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209905-003104415542037-03-10Drug product2019-10-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209905-003111607722037-03-10Drug product2021-12-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209905-003118965622037-03-10U-32992024-02-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209905-004104415542037-03-10Drug product2019-10-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209905-004111607722037-03-10Drug product2021-12-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209905-004118965622037-03-10U-32992024-02-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209905-005104415542037-03-10Drug product2021-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209905-005111607722037-03-10Drug product2021-12-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N209905-001104415542037-03-10Drug product2019-10-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209905-001111607722037-03-10Drug product2021-12-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209905-001118965622037-03-10U-32992024-02-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209905-002104415542037-03-10Drug product2019-10-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209905-002111607722037-03-10Drug product2021-12-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209905-002118965622037-03-10U-32992024-02-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209905-003104415542037-03-10Drug product2019-10-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209905-003111607722037-03-10Drug product2021-12-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209905-003118965622037-03-10U-32992024-02-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209905-004104415542037-03-10Drug product2019-10-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209905-004111607722037-03-10Drug product2021-12-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209905-004118965622037-03-10U-32992024-02-166a471c1ec25d…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24338-033-01EA - Each24338-0334ad7c840-77ba-4269-ba8f-5dd103c2b3a912019-07-02
24338-033-30EA - Each24338-0335fbf6e79-977c-462f-9b67-14cb3b8c37b112019-07-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24338-033-01243380033011 CASE in 1 CARTON (24338-033-01) > 1 BLISTER PACK in 1 CASE (24338-033-30) > 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 case2019-06-280000-00-00NoNoCurrent