Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

Product NDC
64720-130
11-digit product format
647200130
Labeler code
64720
Product ID
64720-130_9abd6536-0cca-45ca-9022-afb13120cece
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
CorePharma, LLC
Application
ANDA040444
Marketing category
ANDA
Marketing start
2007-05-09
Marketing end
2019-11-01
Substance
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE
Active strength
1 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct64720-130DDiscontinued by firm2026-10-05
excluded packagepackage64720-13064720-130-10DDiscontinued by firm2026-10-05

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 packagepackage64720-130-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64720-130-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64720-130-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64720-130-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64720-130-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64720-130-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64720-130-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64720-130-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64720-130-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64720-130-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64720-130-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64720-130-10557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040444-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2002-06-19
A040444-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2002-06-19
A040444-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2002-06-19
A040444-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2002-06-19
A040444-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2014-11-03
A040444-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE3.125MG;3.125MG;3.125MG;3.125MGTABLET / ORALAB2014-11-03
A040444-007DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2014-11-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-productTE code
A040444-001AB
A040444-002AB
A040444-003AB
A040444-004AB
A040444-005AB
A040444-006AB
A040444-007AB

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 8 · 301 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040444-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2002-06-1984e616aacf4f…
2026-09-14 22:38:342026-08A040444-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2002-06-1984e616aacf4f…
2026-09-14 22:38:342026-08A040444-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2002-06-1984e616aacf4f…
2026-09-14 22:38:342026-08A040444-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2002-06-1984e616aacf4f…
2026-09-14 22:38:342026-08A040444-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2014-11-0384e616aacf4f…
2026-09-14 22:38:342026-08A040444-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGTABLET / ORALAB2014-11-0384e616aacf4f…
2026-09-14 22:38:342026-08A040444-007DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2014-11-0384e616aacf4f…
2026-08-18 06:07:402026-07A040444-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2002-06-19caaa826d4ba7…
2026-08-18 06:07:402026-07A040444-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2002-06-19caaa826d4ba7…
2026-08-18 06:07:402026-07A040444-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2002-06-19caaa826d4ba7…
2026-08-18 06:07:402026-07A040444-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2002-06-19caaa826d4ba7…
2026-08-18 06:07:402026-07A040444-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2014-11-03caaa826d4ba7…
2026-08-18 06:07:402026-07A040444-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGTABLET / ORALAB2014-11-03caaa826d4ba7…
2026-08-18 06:07:402026-07A040444-007DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2014-11-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040444-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2002-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040444-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2002-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040444-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2002-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040444-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2002-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040444-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2014-11-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040444-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGTABLET / ORALAB2014-11-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040444-007DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2014-11-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040444-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2002-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040444-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2002-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040444-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2002-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040444-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2002-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040444-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2014-11-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040444-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGTABLET / ORALAB2014-11-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040444-007DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2014-11-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A040444-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2002-06-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040444-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2002-06-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040444-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2002-06-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040444-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2002-06-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040444-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2014-11-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040444-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGTABLET / ORALAB2014-11-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040444-007DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2014-11-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040444-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2002-06-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040444-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2002-06-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040444-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2002-06-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040444-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2002-06-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040444-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2014-11-03fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 301 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A040444-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A040444-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A040444-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A040444-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A040444-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A040444-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A040444-007AB184e616aacf4f…
2026-08-18 06:07:402026-07A040444-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040444-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040444-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040444-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040444-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040444-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040444-007AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040444-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040444-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040444-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040444-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040444-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040444-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040444-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040444-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040444-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040444-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040444-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040444-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040444-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040444-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040444-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040444-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040444-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040444-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040444-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040444-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040444-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040444-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040444-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040444-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040444-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040444-005AB1fd3edfee7708…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64720-130-10EA - Each64720-13046e9c5e8-210a-479c-8e9e-270839feb6da12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMPHETAMINE ASPARTATE MONOHYDRATEACTIVE INGREDIENTO1ZPV620O4DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [COREPHARMA, LLC]39
AMPHETAMINE SULFATEACTIVE INGREDIENT6DPV8NK46SDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [COREPHARMA, LLC]39
DEXTROAMPHETAMINE SACCHARATEACTIVE INGREDIENTG83415V073DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [COREPHARMA, LLC]39
DEXTROAMPHETAMINE SULFATEACTIVE INGREDIENTJJ768O327NDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [COREPHARMA, LLC]39
AMPHETAMINEACTIVE MOIETYCK833KGX7EDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [COREPHARMA, LLC]39
DEXTROAMPHETAMINEACTIVE MOIETYTZ47U051FIDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [COREPHARMA, LLC]39
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [COREPHARMA, LLC]39
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [COREPHARMA, LLC]39
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [COREPHARMA, LLC]39
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [COREPHARMA, LLC]39
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [COREPHARMA, LLC]39
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [COREPHARMA, LLC]39

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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEEpic Pharma, LLC1757e132-061d-4773-89ed-fdc77f69008f2023-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040444
application number: ANDA040444