Dextroamphetamine Sulfate

Product NDC
68382-945
11-digit product format
683820945
Labeler code
68382
Product ID
68382-945_7a16d81a-a695-478a-9eb1-f09843699173
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextroamphetamine Sulfate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA209111
Marketing category
ANDA
Marketing start
2017-06-28
Marketing end
0000-00-00
Substance
DEXTROAMPHETAMINE SULFATE
Active strength
15 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68382-945IInactivated by FDA2026-08-17
excluded packagepackage68382-94568382-945-01IInactivated by FDA2026-08-17

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 · 32 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 packagepackage68382-945-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-945-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-945-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-945-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-945-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-945-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-945-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68382-945-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68382-945-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68382-945-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68382-945-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68382-945-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68382-945-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68382-945-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68382-945-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68382-945-01fb8cb913e6d1…eb8c232b6be0…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209111-001DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27
A209111-002DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27
A209111-003DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209111-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27caaa826d4ba7…
2026-08-18 06:07:402026-07A209111-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27caaa826d4ba7…
2026-08-18 06:07:402026-07A209111-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209111-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209111-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209111-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209111-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209111-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209111-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A209111-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209111-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209111-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209111-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209111-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209111-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209111-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209111-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209111-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209111-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209111-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209111-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209111-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209111-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209111-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209111-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209111-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209111-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209111-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209111-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209111-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209111-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A209111-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A209111-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209111-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209111-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209111-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209111-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209111-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209111-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209111-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-271e350fbaab3a…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-04 05:41 UTC2022-04A209111-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209111-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209111-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209111-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209111-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209111-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209111-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209111-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209111-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209111-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A209111-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A209111-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209111-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209111-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209111-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A209111-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A209111-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A209111-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209111-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A209111-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A209111-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209111-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A209111-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A209111-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209111-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A209111-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A209111-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A209111-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A209111-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A209111-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209111-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A209111-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A209111-003AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f66b30d-6b15-4b2d-91a5-1531b9bb6d21Product name720250625
917bdf48-c3f5-4a58-ac8e-d2d94a9c1e2bProduct name220250616
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b4c312b9-fad5-247e-cef9-87a74220463dProduct name520230426
8170729e-5ba4-46f9-830f-5f0fae5942ceProduct name120230103
2a7aa275-a4ca-44eb-971f-47427a374085Product name920220615
aa1b3c66-c4f6-78f2-abd3-31cc9d555e27Product name520190913
b4c312b9-fad5-247e-cef9-87a74220463dProduct name420171211
ffdf7f68-0f44-4dd6-a026-336dcb345fc4Product name120151109

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68382-945-012022-07-29C16284748780-1e4f33bdf-b135-d8a0-e053-dadaa90a6e4eDextroamphetamine Sulfate Extended-Release Capsules CII Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-945-01Dextroamphetamine Sulfate100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-945DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC. ]8Legacy NDC, 1 package rows20211218_124c91d5-b533-4caa-aa14-81f1dba9fa90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884520dextroamphetamine sulfate 10 MG Extended Release Oral CapsulePSN124c91d5-b533-4caa-aa14-81f1dba9fa908
884532dextroamphetamine sulfate 15 MG Extended Release Oral CapsulePSN124c91d5-b533-4caa-aa14-81f1dba9fa908
884535dextroamphetamine sulfate 5 MG Extended Release Oral CapsulePSN124c91d5-b533-4caa-aa14-81f1dba9fa908
884520dextroamphetamine sulfate 10 MG Extended Release Oral CapsuleSCD124c91d5-b533-4caa-aa14-81f1dba9fa908
884532dextroamphetamine sulfate 15 MG Extended Release Oral CapsuleSCD124c91d5-b533-4caa-aa14-81f1dba9fa908
884535dextroamphetamine sulfate 5 MG Extended Release Oral CapsuleSCD124c91d5-b533-4caa-aa14-81f1dba9fa908

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-945-0168382094501100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-945-01) 2017-06-280000-00-00NoNoCurrent