Evekeo

Product NDC
24338-022
11-digit product format
243380022
Labeler code
24338
Product ID
24338-022_d0fd9643-77a8-4810-94f5-f0ab06e4212f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amphetamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Azurity Pharmaceuticals, Inc.
Application
ANDA200166
Marketing category
ANDA
Marketing start
2015-11-01
Substance
AMPHETAMINE SULFATE
Active strength
5 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage24338-02224338-022-10DDiscontinued 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200166-001EVEKEOAMPHETAMINE SULFATE5MGTABLET / ORALAA2012-08-09
A200166-002EVEKEOAMPHETAMINE SULFATE10MGTABLET / ORALAARS2012-08-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200166-001AA
A200166-002AA

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 UTC2026-02A200166-001EVEKEO5MGTABLET / ORALAA2012-08-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200166-002EVEKEO10MGTABLET / ORALAARS2012-08-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200166-001EVEKEO5MGTABLET / ORALAA2012-08-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200166-002EVEKEO10MGTABLET / ORALAARS2012-08-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A200166-001EVEKEO5MGTABLET / ORALAA2012-08-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200166-002EVEKEO10MGTABLET / ORALAARS2012-08-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200166-001EVEKEO5MGTABLET / ORALAA2012-08-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200166-002EVEKEO10MGTABLET / ORALAARS2012-08-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200166-001EVEKEO5MGTABLET / ORALAA2012-08-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200166-002EVEKEO10MGTABLET / ORALAARS2012-08-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200166-001EVEKEO5MGTABLET / ORALAA2012-08-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200166-002EVEKEO10MGTABLET / ORALAARS2012-08-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200166-001EVEKEO5MGTABLET / ORALAA2012-08-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200166-002EVEKEO10MGTABLET / ORALAARS2012-08-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200166-001EVEKEO5MGTABLET / ORALAA2012-08-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200166-002EVEKEO10MGTABLET / ORALAARS2012-08-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200166-001EVEKEO5MGTABLET / ORALAA2012-08-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200166-002EVEKEO10MGTABLET / ORALAARS2012-08-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200166-001EVEKEO5MGTABLET / ORALAA2012-08-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A200166-002EVEKEO10MGTABLET / ORALAARS2012-08-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200166-001EVEKEO5MGTABLET / ORALAA2012-08-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200166-002EVEKEO10MGTABLET / ORALAARS2012-08-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200166-001EVEKEO5MGTABLET / ORALAA2012-08-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200166-002EVEKEO10MGTABLET / ORALAARS2012-08-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200166-001EVEKEO5MGTABLET / ORALAA2012-08-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200166-002EVEKEO10MGTABLET / ORALAARS2012-08-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200166-001EVEKEO5MGTABLET / ORALAA2012-08-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200166-002EVEKEO10MGTABLET / ORALAARS2012-08-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200166-001EVEKEO5MGTABLET / ORALAA2012-08-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200166-002EVEKEO10MGTABLET / ORALAARS2012-08-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200166-001EVEKEO5MGTABLET / ORALAA2012-08-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200166-002EVEKEO10MGTABLET / ORALAARS2012-08-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200166-001EVEKEO5MGTABLET / ORALAA2012-08-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200166-002EVEKEO10MGTABLET / ORALAARS2012-08-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200166-001EVEKEO5MGTABLET / ORALAA2012-08-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200166-002EVEKEO10MGTABLET / ORALAARS2012-08-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200166-001EVEKEO5MGTABLET / ORALAA2012-08-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200166-002EVEKEO10MGTABLET / ORALAARS2012-08-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200166-001EVEKEO5MGTABLET / ORALAA2012-08-09782e0a99824c…
2021-12-28 21:50 UTC2021-12A200166-002EVEKEO10MGTABLET / ORALAARS2012-08-09782e0a99824c…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A200166-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200166-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200166-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200166-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200166-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200166-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200166-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200166-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200166-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200166-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200166-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200166-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200166-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200166-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200166-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200166-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200166-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200166-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200166-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200166-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200166-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200166-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200166-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200166-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200166-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200166-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200166-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200166-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200166-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200166-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200166-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200166-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200166-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200166-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200166-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200166-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200166-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200166-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200166-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A200166-002AA1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPHETAMINE SULFATE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6DPV8NK46SInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
884655Internal RxNorm lookup
1600695Internal RxNorm lookup
1600698Internal RxNorm lookup
1600700Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f469fb38-0380-4621-9db3-a4f429126156Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f66b30d-6b15-4b2d-91a5-1531b9bb6d21Product name720250625
917bdf48-c3f5-4a58-ac8e-d2d94a9c1e2bProduct name220250616
8b92ab59-8b26-4c89-a2d6-8d5140526ec6Product name320231213
4496d022-9224-4ee0-943a-50fbe6cd7123Product name220220901
2a7aa275-a4ca-44eb-971f-47427a374085Product name920220615
93730fbf-8b45-4623-b27d-cf03825d04b3Product name520220314
57953747-955c-4dd8-9164-49d8ea877eaeProduct name120171113
fcc7ea58-a369-4e91-b092-5cde9ac2669fProduct name120160224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24338-022-03Evekeo30 in 1 BOTTLETABLET309
24338-022-10Evekeo100 in 1 BOTTLETABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24338-022-03EA - Each24338-022ddd7fbd6-f49a-4b6f-b62a-62c6f814915912021-04-08
24338-022-10EA - Each24338-0229fb542b1-88d9-43a5-abc0-8fdd1de99e3e12016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Amphetamine SulfateACTIVE INGREDIENT6DPV8NK46SEVEKEO (AMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS]1
AmphetamineACTIVE MOIETYCK833KGX7EEVEKEO (AMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UEVEKEO (AMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS]1
crospovidoneINACTIVE INGREDIENT68401960MKEVEKEO (AMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDEVEKEO (AMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APEVEKEO (AMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24338-022EVEKEO (AMPHETAMINE SULFATE) TABLET [AZURITY PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 2 package rows20231101_f469fb38-0380-4621-9db3-a4f429126156.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amphetamine SulfateAMPHETAMINE SULFATEBryant Ranch Prepackb94e2562-fd19-455f-ac10-2cc24302d27a2026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200166
application number: ANDA200166
Amphetamine SulfateAMPHETAMINE SULFATEBryant Ranch Prepack920f99f4-ab78-4eed-9d80-08a2ebd0b7692026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200166
application number: ANDA200166
Amphetamine SulfateAMPHETAMINE SULFATEWilshire Pharmaceuticals, Inc.91add2e3-8359-47dc-b79f-197d36b028192025-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200166
application number: ANDA200166
EvekeoAMPHETAMINE SULFATEAzurity Pharmaceuticals, Inc.f469fb38-0380-4621-9db3-a4f4291261562025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200166
application number: ANDA200166
ndc (product): 24338-022
Amphetamine SulfateAMPHETAMINE SULFATEBryant Ranch Prepack674940ec-1714-4e41-b471-2a8c8a6c5ade2025-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200166
application number: ANDA200166
Amphetamine SulfateAMPHETAMINE SULFATEBryant Ranch Prepackc972a6a4-a96c-4d70-b4c4-eef9e990abb42025-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200166
application number: ANDA200166

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1600695amphetamine sulfate 10 MG Oral TabletPSNf469fb38-0380-4621-9db3-a4f4291261569
884655amphetamine sulfate 5 MG Oral TabletPSNf469fb38-0380-4621-9db3-a4f4291261569
1600698Evekeo 10 MG Oral TabletPSNf469fb38-0380-4621-9db3-a4f4291261569
1600700Evekeo 5 MG Oral TabletPSNf469fb38-0380-4621-9db3-a4f4291261569
1600698amphetamine sulfate 10 MG Oral Tablet [Evekeo]SBDf469fb38-0380-4621-9db3-a4f4291261569
1600700amphetamine sulfate 5 MG Oral Tablet [Evekeo]SBDf469fb38-0380-4621-9db3-a4f4291261569
1600695amphetamine sulfate 10 MG Oral TabletSCDf469fb38-0380-4621-9db3-a4f4291261569
884655amphetamine sulfate 5 MG Oral TabletSCDf469fb38-0380-4621-9db3-a4f4291261569
1600698Evekeo 10 MG Oral TabletSYf469fb38-0380-4621-9db3-a4f4291261569
1600700Evekeo 5 MG Oral TabletSYf469fb38-0380-4621-9db3-a4f4291261569

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24338-022-032433800220330 TABLET in 1 BOTTLE (24338-022-03) 30 tablet2021-03-120000-00-00NoNoCurrent
24338-022-1024338002210100 TABLET in 1 BOTTLE (24338-022-10) 100 tablet2015-11-010000-00-00NoNoCurrent