BENZPHETAMINE HYDROCHLORIDE

Product NDC
50090-1024
11-digit product format
500901024
Labeler code
50090
Product ID
50090-1024_074ec8cd-f5d7-41d3-a78c-db311736ae15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzphetamine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090968
Marketing category
ANDA
Marketing start
2010-07-21
Marketing end
0000-00-00
Substance
BENZPHETAMINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]
DEA schedule
CIII
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-1024DDiscontinued by firm2026-08-17
excluded packagepackage50090-102450090-1024-1DDiscontinued by firm2026-08-17
excluded packagepackage50090-102450090-1024-2DDiscontinued by firm2026-08-17

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 · 27 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 packagepackage50090-1024-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-1024-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-1024-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-1024-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-1024-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-1024-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-1024-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-1024-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-1024-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-1024-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-1024-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-1024-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-1024-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-1024-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-1024-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-1024-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-1024-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-1024-20efc9e666f02…f202fb6c5f17…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090968-001BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090968-001AA

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-203f01610625f2…
2019-09-15 20:21 UTC2019-09A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090968-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090968-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090968-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090968-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090968-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090968-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090968-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090968-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090968-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090968-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090968-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090968-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090968-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090968-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090968-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090968-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090968-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090968-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090968-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090968-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090968-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090968-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A090968-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090968-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090968-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090968-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A090968-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090968-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090968-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090968-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090968-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090968-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090968-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090968-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090968-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090968-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090968-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090968-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090968-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090968-001AA1e64feba35796…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1024-1EA - Each50090-102423181fa3-8d1c-4cda-826e-b60108507aed12018-10-11
50090-1024-2EA - Each50090-10244230c3fa-d9f3-4a66-92d6-df49517e8e1f12018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZPHETAMINE HYDROCHLORIDEACTIVE INGREDIENT43DWT87QT7BENZPHETAMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
BENZPHETAMINEACTIVE MOIETY0M3S43XK27BENZPHETAMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBENZPHETAMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABENZPHETAMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BENZPHETAMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENZPHETAMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENZPHETAMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PBENZPHETAMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990BENZPHETAMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BENZPHETAMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BENZPHETAMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBENZPHETAMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENZPHETAMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDEKVK-TECH, INC14d4589d-7f1c-4b6e-9557-59dad39b09602026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090968
application number: ANDA090968
BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2b7014af-0cc9-4199-90f2-ec07ac02f8cf2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090968
application number: ANDA090968
BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDEBryant Ranch Prepack1c726aa7-3b78-45de-aca0-fd8a5fff94032024-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090968
application number: ANDA090968
benzphetamine hydrochlorideBENZPHETAMINE HYDROCHLORIDECalvin Scott & Co., Inc.f5c3c2ed-54a2-1def-e053-2995a90ab4e32023-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090968
application number: ANDA090968

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1024-15009010240160 TABLET in 1 BOTTLE (50090-1024-1) 60 tablet2015-11-200000-00-00NoNoCurrent
50090-1024-25009010240290 TABLET in 1 BOTTLE (50090-1024-2) 90 tablet2014-11-280000-00-00NoNoCurrent