BENZPHETAMINE HYDROCHLORIDE

Product NDC
33261-458
11-digit product format
332610458
Labeler code
33261
Product ID
33261-458_9f37c87d-020c-4e5c-b3b9-dfae7d38ae62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzphetamine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
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
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct33261-458IInactivated by FDA2026-08-07
excluded packagepackage33261-45833261-458-90IInactivated by FDA2026-08-07

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 · 42 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 packagepackage33261-458-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-458-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-458-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-458-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-458-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-458-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-458-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-458-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-458-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-458-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-458-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-458-90557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage33261-458-908af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage33261-458-90834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage33261-458-901332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage33261-458-90fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage33261-458-9086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage33261-458-90bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage33261-458-908dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage33261-458-90e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage33261-458-909bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090968-001BENZPHETAMINE 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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090968-001AA1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-458-902020-01-31C16284748780-19d75b9d0-cd1e-f424-e053-dadaa90a57ceBenzphetamine Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-458-90BENZPHETAMINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-458-90EA - Each33261-458af5b9cd0-c2c8-42ee-a25f-ae305e9ee3ec12015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-458BENZPHETAMINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140106_082a9bcf-f1ea-4c77-86e0-3699720514be.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904368benzphetamine HCl 50 MG Oral TabletPSN082a9bcf-f1ea-4c77-86e0-3699720514be1
904368benzphetamine hydrochloride 50 MG Oral TabletSCD082a9bcf-f1ea-4c77-86e0-3699720514be1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-458-903326104589090 in 1 BOTTLE, PLASTICHistorical