AMPHETAMINE SULFATE

Product NDC
71337-024
11-digit product format
713370024
Labeler code
71337
Product ID
71337-024_6c7f2ea6-a673-4e70-9a39-6067057fe6d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMPHETAMINE SULFATE
Dosage form
TABLET
Route
ORAL
Labeler
Havix Group Inc d-b-a Aavis Pharmaceuticals
Application
ANDA212901
Marketing category
ANDA
Marketing start
2020-10-22
Marketing end
0000-00-00
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
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71337-024DDiscontinued by firm2026-08-10
excluded packagepackage71337-02471337-024-01DDiscontinued by firm2026-08-10

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71337-024-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71337-024-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71337-024-01DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71337-024-01DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71337-024-01DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71337-024-01DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71337-024-01DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71337-024-01DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71337-024-01DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71337-024-01DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71337-024-01DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71337-024-01DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage71337-024-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage71337-024-01IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage71337-024-01IInactivated by FDAbd6a592717d7…303034d00443…

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
A212901-001AMPHETAMINE SULFATEAMPHETAMINE SULFATE5MGTABLET / ORALAA2020-05-22
A212901-002AMPHETAMINE SULFATEAMPHETAMINE SULFATE10MGTABLET / ORALAA2020-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212901-001AA
A212901-002AA

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 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212901-001AMPHETAMINE SULFATE5MGTABLET / ORALAA2020-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212901-002AMPHETAMINE SULFATE10MGTABLET / ORALAA2020-05-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212901-001AMPHETAMINE SULFATE5MGTABLET / ORALAA2020-05-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212901-002AMPHETAMINE SULFATE10MGTABLET / ORALAA2020-05-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A212901-001AMPHETAMINE SULFATE5MGTABLET / ORALAA2020-05-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212901-002AMPHETAMINE SULFATE10MGTABLET / ORALAA2020-05-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212901-001AMPHETAMINE SULFATE5MGTABLET / ORALAA2020-05-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212901-002AMPHETAMINE SULFATE10MGTABLET / ORALAA2020-05-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212901-001AMPHETAMINE SULFATE5MGTABLET / ORALAA2020-05-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212901-002AMPHETAMINE SULFATE10MGTABLET / ORALAA2020-05-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212901-001AMPHETAMINE SULFATE5MGTABLET / ORALAA2020-05-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212901-002AMPHETAMINE SULFATE10MGTABLET / ORALAA2020-05-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212901-001AMPHETAMINE SULFATE5MGTABLET / ORALAA2020-05-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212901-002AMPHETAMINE SULFATE10MGTABLET / ORALAA2020-05-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212901-001AMPHETAMINE SULFATE5MGTABLET / ORALAA2020-05-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212901-002AMPHETAMINE SULFATE10MGTABLET / ORALAA2020-05-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212901-001AMPHETAMINE SULFATE5MGTABLET / ORALAA2020-05-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212901-002AMPHETAMINE SULFATE10MGTABLET / ORALAA2020-05-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212901-001AMPHETAMINE SULFATE5MGTABLET / ORALAA2020-05-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A212901-002AMPHETAMINE SULFATE10MGTABLET / ORALAA2020-05-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212901-001AMPHETAMINE SULFATE5MGTABLET / ORALAA2020-05-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212901-002AMPHETAMINE SULFATE10MGTABLET / ORALAA2020-05-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212901-001AMPHETAMINE SULFATE5MGTABLET / ORALAA2020-05-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212901-002AMPHETAMINE SULFATE10MGTABLET / ORALAA2020-05-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212901-001AMPHETAMINE SULFATE5MGTABLET / ORALAA2020-05-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212901-002AMPHETAMINE SULFATE10MGTABLET / ORALAA2020-05-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212901-001AMPHETAMINE SULFATE5MGTABLET / ORALAA2020-05-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212901-002AMPHETAMINE SULFATE10MGTABLET / ORALAA2020-05-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212901-001AMPHETAMINE SULFATE5MGTABLET / ORALAA2020-05-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212901-002AMPHETAMINE SULFATE10MGTABLET / ORALAA2020-05-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212901-001AMPHETAMINE SULFATE5MGTABLET / ORALAA2020-05-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212901-002AMPHETAMINE SULFATE10MGTABLET / ORALAA2020-05-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212901-001AMPHETAMINE SULFATE5MGTABLET / ORALAA2020-05-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212901-002AMPHETAMINE SULFATE10MGTABLET / ORALAA2020-05-224b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212901-001AMPHETAMINE SULFATE5MGTABLET / ORALAA2020-05-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212901-002AMPHETAMINE SULFATE10MGTABLET / ORALAA2020-05-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212901-001AMPHETAMINE SULFATE5MGTABLET / ORALAA2020-05-22782e0a99824c…
2021-12-28 21:50 UTC2021-12A212901-002AMPHETAMINE SULFATE10MGTABLET / ORALAA2020-05-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212901-001AMPHETAMINE SULFATE5MGTABLET / ORALAA2020-05-2287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212901-002AMPHETAMINE SULFATE10MGTABLET / ORALAA2020-05-2287673890dc5c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212901-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212901-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212901-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212901-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212901-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212901-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212901-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212901-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212901-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212901-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212901-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212901-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212901-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212901-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212901-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212901-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212901-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212901-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212901-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212901-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212901-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212901-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212901-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212901-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212901-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212901-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212901-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212901-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212901-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212901-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212901-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212901-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212901-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212901-002AA14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212901-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212901-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212901-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A212901-002AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212901-001AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212901-002AA187673890dc5c…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71337-024-012022-12-05C16284748780-1d6a99b39-cb6e-a426-e053-dadaa90af4c2Amphetamine Sulfate Tablets, USP CII
71337-024-012022-01-28C16284748780-1d6a99b39-cb6e-a426-e053-dadaa90af4c2Amphetamine Sulfate Tablets, USP CII

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amphetamine SulfateAMPHETAMINE SULFATEAmici Pharma, Inc.e045dc28-e05d-4407-9d44-d0a11ca558e62026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212901
application number: ANDA212901
AMPHETAMINE SULFATEAMPHETAMINE SULFATEBryant Ranch Prepack9817a519-fdb0-474a-92f4-2e485c9cb0472026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212901
application number: ANDA212901
AMPHETAMINE SULFATEAMPHETAMINE SULFATEBryant Ranch Prepack9eb84b3c-2147-42dd-8053-6afd1a88b0c12025-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212901
application number: ANDA212901
AMPHETAMINE SULFATEAMPHETAMINE SULFATEBryant Ranch Prepack3ad894e3-78a7-4e3b-80d1-1a925fb6d9e32024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212901
application number: ANDA212901
AMPHETAMINE SULFATEAMPHETAMINE SULFATEBryant Ranch Prepack698171ee-4328-476a-b71c-58aa6dc93b232024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212901
application number: ANDA212901
AMPHETAMINE SULFATEAMPHETAMINE SULFATEBryant Ranch Prepackc00bbade-3dc8-422b-8cff-f85db408bdfc2024-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212901
application number: ANDA212901
AMPHETAMINE SULFATEAMPHETAMINE SULFATELannett Company, Inc.85a015a7-a1a0-4b04-8bc4-7aacd0c847422024-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212901
application number: ANDA212901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71337-024-0171337002401100 TABLET in 1 BOTTLE (71337-024-01) 100 tablet2020-10-230000-00-00NoNoCurrent