Benzphetamine Hydrochloride

Product NDC
53217-175
11-digit product format
532170175
Labeler code
53217
Product ID
53217-175_3904530d-83e6-4359-b6a9-63f15b0366f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzphetamine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA040747
Marketing category
ANDA
Marketing start
2010-09-07
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
2019-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53217-175IInactivated by FDA2026-08-17
excluded packagepackage53217-17553217-175-07IInactivated by FDA2026-08-17
excluded packagepackage53217-17553217-175-14IInactivated by FDA2026-08-17
excluded packagepackage53217-17553217-175-21IInactivated by FDA2026-08-17
excluded packagepackage53217-17553217-175-42IInactivated by FDA2026-08-17
excluded packagepackage53217-17553217-175-84IInactivated by FDA2026-08-17
excluded packagepackage53217-17553217-175-90IInactivated 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 3 · 147 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 packagepackage53217-175-84d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53217-175-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53217-175-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53217-175-42d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53217-175-21d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53217-175-07d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53217-175-84f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53217-175-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53217-175-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53217-175-42f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53217-175-21f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53217-175-07f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53217-175-842ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53217-175-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53217-175-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53217-175-422ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53217-175-212ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53217-175-072ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53217-175-84a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53217-175-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53217-175-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53217-175-42a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53217-175-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53217-175-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53217-175-84cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53217-175-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53217-175-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53217-175-42cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53217-175-21cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53217-175-07cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53217-175-84cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53217-175-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53217-175-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53217-175-42cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53217-175-21cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53217-175-07cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53217-175-84302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53217-175-14302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53217-175-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53217-175-42302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53217-175-21302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53217-175-07302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53217-175-84ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53217-175-14ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53217-175-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53217-175-42ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53217-175-21ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53217-175-07ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53217-175-840efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53217-175-140efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53217-175-900efc9e666f02…f202fb6c5f17…

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

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
A040747-001BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-03-30
A040747-002BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2015-11-20

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040747-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07A040747-002BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2015-11-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040747-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040747-002BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2015-11-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040747-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040747-002BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2015-11-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040747-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040747-002BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2015-11-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040747-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040747-002BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2015-11-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040747-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040747-002BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2015-11-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040747-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040747-002BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2015-11-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040747-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040747-002BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2015-11-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040747-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040747-002BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2015-11-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040747-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-03-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040747-002BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2015-11-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040747-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-03-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A040747-002BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2015-11-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040747-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-03-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040747-002BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2015-11-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040747-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-03-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040747-002BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2015-11-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040747-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-03-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040747-002BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2015-11-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040747-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-03-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040747-002BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2015-11-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040747-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-03-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040747-002BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2015-11-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040747-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-03-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040747-002BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2015-11-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040747-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-03-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040747-002BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2015-11-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040747-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040747-002BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2015-11-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040747-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-03-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040747-002BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2015-11-20bb7c543d1eb4…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e1de3598-2dc1-55e2-fc07-ee2e74c73cfcProduct name320201013
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-175-07Benzphetamine Hydrochloride7 in 1 BOTTLETABLET71
53217-175-14Benzphetamine Hydrochloride14 in 1 BOTTLETABLET141
53217-175-21Benzphetamine Hydrochloride21 in 1 BOTTLETABLET211
53217-175-42Benzphetamine Hydrochloride42 in 1 BOTTLETABLET421
53217-175-84Benzphetamine Hydrochloride84 in 1 BOTTLETABLET841
53217-175-90Benzphetamine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-175-07EA - Each53217-175658aa36c-5d8d-4589-9e8a-41074a318af412016-12-07
53217-175-14EA - Each53217-1753108b0a1-ac54-450c-9a67-3715d5165e7912016-12-07
53217-175-21EA - Each53217-1757d5247e2-0a9d-4f49-a8a3-df643715ae5412016-12-07
53217-175-42EA - Each53217-175ec48eb9c-6654-4e29-8a01-89eb152c0ad912016-12-07
53217-175-84EA - Each53217-175688f086e-dba0-45c7-acd6-0fb85965b0e912016-12-07
53217-175-90EA - Each53217-17566a81cb5-68b2-4f79-9a68-395eeaf81e4e12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-175BENZPHETAMINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 6 package rows20161206_5ca0eee3-8f84-4ee2-b339-c9cdbf6ffd52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904368benzphetamine HCl 50 MG Oral TabletPSN5ca0eee3-8f84-4ee2-b339-c9cdbf6ffd521
904368benzphetamine hydrochloride 50 MG Oral TabletSCD5ca0eee3-8f84-4ee2-b339-c9cdbf6ffd521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-175-07532170175077 in 1 BOTTLEHistorical
53217-175-145321701751414 in 1 BOTTLEHistorical
53217-175-215321701752121 in 1 BOTTLEHistorical
53217-175-425321701754242 in 1 BOTTLEHistorical
53217-175-845321701758484 in 1 BOTTLEHistorical
53217-175-905321701759090 in 1 BOTTLEHistorical