FDA.reportPublic FDA data

BENZPHETAMINE HYDROCHLORIDE

Product NDC
50090-1024
Requested package NDC
50090-1024-2
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-102450090-1024-2DDiscontinued by firm2026-07-31

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090968-001AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 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

Packages#

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