Benzphetamine Hydrochloride

Product NDC
23155-174
11-digit product format
231550174
Labeler code
23155
Product ID
23155-174_f1aa29b6-d272-4559-a5a9-d18ea95a7519
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzphetamine Hydrochloride Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA202061
Marketing category
ANDA
Marketing start
2012-10-19
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
2020-12-31
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 productproduct23155-174DDiscontinued by firm2026-08-17
excluded packagepackage23155-17423155-174-01DDiscontinued by firm2026-08-17
excluded packagepackage23155-17423155-174-03DDiscontinued 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 · 36 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 packagepackage23155-174-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage23155-174-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage23155-174-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage23155-174-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage23155-174-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage23155-174-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage23155-174-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage23155-174-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage23155-174-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage23155-174-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage23155-174-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage23155-174-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage23155-174-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage23155-174-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage23155-174-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage23155-174-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage23155-174-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage23155-174-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage23155-174-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage23155-174-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage23155-174-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage23155-174-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage23155-174-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage23155-174-03557ba5c1ecfa…9c80585c8c6e…

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
A202061-001BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2012-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202061-001AA

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 06:07:402026-07A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2012-01-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2012-01-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2012-01-273f01610625f2…
2019-09-15 20:21 UTC2019-09A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2012-01-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2012-01-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202061-001AA1caaa826d4ba7…
2019-12-13 00:20 UTC2019-12A202061-001AA174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A202061-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A202061-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202061-001AA1ea99ee380514…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202061-001AA1a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-174-01EA - Each23155-174f0a09b38-a405-4c4e-a635-d45d8adc7d2d12012-07-24
23155-174-03EA - Each23155-1746b9c1769-51ad-42f0-8b8e-0bca1145c80e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZPHETAMINE HYDROCHLORIDEACTIVE INGREDIENT43DWT87QT7BENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC.]10
BENZPHETAMINEACTIVE MOIETY0M3S43XK27BENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC.]10
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LBENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC.]10
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC.]10
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC.]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC.]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC.]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC.]10
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC.]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC.]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC.]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC.]10

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
Benzphetamine HydrochlorideBENZPHETAMINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.152a123e-4886-4184-a47d-462ce102b8fa2026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202061
application number: ANDA202061