dextroamphetamine sulfate

Product NDC
51862-345
11-digit product format
518620345
Labeler code
51862
Product ID
51862-345_348dccbd-c876-417c-a849-0059aec5516c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dextroamphetamine sulfate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Mayne Pharma Inc.
Application
ANDA203901
Marketing category
ANDA
Marketing start
2016-08-05
Marketing end
0000-00-00
Substance
DEXTROAMPHETAMINE 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
2021-12-31
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 productproduct51862-345DDiscontinued by firm2026-08-03
excluded packagepackage51862-34551862-345-90DDiscontinued by firm2026-08-03

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 · 24 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 packagepackage51862-345-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51862-345-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51862-345-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51862-345-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51862-345-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51862-345-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51862-345-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51862-345-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51862-345-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51862-345-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51862-345-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51862-345-90557ba5c1ecfa…9c80585c8c6e…

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

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
A203901-001DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-30
A203901-002DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-30
A203901-003DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A203901-001AB
A203901-002AB
A203901-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203901-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203901-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203901-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203901-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203901-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203901-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A203901-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203901-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203901-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203901-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203901-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203901-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203901-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203901-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203901-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203901-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203901-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203901-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203901-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203901-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203901-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203901-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203901-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203901-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203901-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203901-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203901-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203901-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A203901-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A203901-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203901-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203901-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203901-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203901-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203901-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203901-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203901-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203901-002DEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203901-003DEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203901-001DEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORALAB2012-11-308072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203901-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203901-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203901-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203901-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203901-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203901-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203901-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203901-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203901-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203901-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203901-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203901-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203901-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203901-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203901-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203901-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203901-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203901-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203901-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203901-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203901-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203901-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203901-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203901-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203901-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203901-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203901-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203901-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203901-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203901-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203901-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203901-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203901-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203901-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203901-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203901-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203901-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203901-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203901-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203901-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51862-345-90EA - Each51862-3454ad71b46-0bf7-417f-8c4e-11afa1b1318112016-09-02

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dextroamphetamine sulfateDEXTROAMPHETAMINE SULFATEActavis Pharma, Inc.9e92ccc3-d81c-461d-a19f-7e9b582be3572026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203901
application number: ANDA203901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51862-345-905186203459090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51862-345-90) 2016-08-050000-00-00NoNoCurrent