benzphetamine hydrochloride

Product NDC
43547-263
11-digit product format
435470263
Labeler code
43547
Product ID
43547-263_48be1cda-69dc-46d9-a2c4-55d4a5ef04fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzphetamine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare US LLC
Application
ANDA090473
Marketing category
ANDA
Marketing start
2011-08-01
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
E
Listing certified through
2017-12-31
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 productproduct43547-263DDiscontinued by firm2026-08-17
excluded packagepackage43547-26343547-263-10DDiscontinued by firm2026-08-17
excluded packagepackage43547-26343547-263-50DDiscontinued 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 · 39 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 packagepackage43547-263-10DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43547-263-50DDiscontinued 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 packagepackage43547-263-10DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43547-263-50DDiscontinued 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 packagepackage43547-263-10DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43547-263-50DDiscontinued 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 packagepackage43547-263-10DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43547-263-50DDiscontinued 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 packagepackage43547-263-10DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43547-263-50DDiscontinued 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 packagepackage43547-263-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43547-263-50DDiscontinued 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 packagepackage43547-263-10DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43547-263-50DDiscontinued 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 packagepackage43547-263-10DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43547-263-50DDiscontinued 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 packagepackage43547-263-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43547-263-50DDiscontinued 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 packagepackage43547-263-10DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43547-263-50DDiscontinued 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 packagepackage43547-263-10DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43547-263-50DDiscontinued 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 packagepackage43547-263-10DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43547-263-50DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage43547-263-10IInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage43547-263-50IInactivated by FDA110d247fa046…a55b01930146…

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
A090473-001BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-09-15
A090473-002BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2010-09-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090473-002AA

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090473-001BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-09-15caaa826d4ba7…
2026-08-18 06:07:402026-07A090473-002BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2010-09-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090473-001BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090473-002BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2010-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090473-001BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090473-002BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2010-09-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090473-001BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090473-002BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2010-09-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090473-001BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090473-002BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2010-09-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090473-001BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090473-002BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2010-09-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090473-001BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090473-002BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2010-09-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090473-001BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090473-002BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2010-09-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090473-001BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-09-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090473-002BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2010-09-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090473-001BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-09-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090473-002BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2010-09-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090473-001BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-09-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A090473-002BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2010-09-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090473-001BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-09-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090473-002BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2010-09-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090473-001BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-09-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090473-002BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2010-09-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090473-001BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-09-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090473-002BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2010-09-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090473-001BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-09-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090473-002BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2010-09-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090473-001BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-09-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090473-002BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2010-09-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090473-001BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-09-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090473-002BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2010-09-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090473-001BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-09-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090473-002BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2010-09-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090473-001BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-09-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090473-002BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2010-09-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090473-001BENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-09-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090473-002BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2010-09-15bb7c543d1eb4…

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 06:07:402026-07A090473-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090473-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090473-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090473-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090473-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090473-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090473-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090473-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090473-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090473-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090473-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090473-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090473-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090473-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090473-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090473-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090473-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090473-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090473-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090473-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090473-002AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090473-002AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A090473-002AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090473-002AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090473-002AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090473-002AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A090473-002AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090473-002AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090473-002AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090473-002AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090473-002AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090473-002AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090473-002AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090473-002AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090473-002AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090473-002AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090473-002AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090473-002AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090473-002AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090473-002AA1e64feba35796…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-263-10EA - Each43547-263175de264-29dc-4947-9e4a-fe52360ff73412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
benzphetamine hydrochlorideACTIVE INGREDIENT43DWT87QT7BENZPHETAMINE HYDROCHLORIDE TABLET [SOLCO HEALTHCARE US LLC]1
benzphetamineACTIVE MOIETY0M3S43XK27BENZPHETAMINE HYDROCHLORIDE TABLET [SOLCO HEALTHCARE US LLC]1
calcium stearateINACTIVE INGREDIENT776XM7047LBENZPHETAMINE HYDROCHLORIDE TABLET [SOLCO HEALTHCARE US LLC]1
d&c red no. 30INACTIVE INGREDIENT2S42T2808BBENZPHETAMINE HYDROCHLORIDE TABLET [SOLCO HEALTHCARE US LLC]1
sorbitolINACTIVE INGREDIENT506T60A25RBENZPHETAMINE HYDROCHLORIDE TABLET [SOLCO HEALTHCARE US LLC]1
starch, cornINACTIVE INGREDIENTO8232NY3SJBENZPHETAMINE HYDROCHLORIDE TABLET [SOLCO HEALTHCARE US LLC]1