FDA.reportPublic FDA data

BENZPHETAMINE HYDROCHLORIDE

Product NDC
10702-040
11-digit product format
107020040
Labeler code
10702
Product ID
10702-040_15d75638-8ac7-e610-e063-6394a90af99c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzphetamine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
KVK-TECH, INC
Application
ANDA090968
Marketing category
ANDA
Marketing start
2010-07-21
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BENZPHETAMINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZPHETAMINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii43DWT87QT7
Rxcui904368

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
10702-040-012024-04-11C16284748780-11030e365-3875-111a-e063-dadaa90a10e2Benzphetamine Hydrochloride Tablets CIII Rx Only
10702-040-032024-04-11C16284748780-11030e365-3875-111a-e063-dadaa90a10e2Benzphetamine Hydrochloride Tablets CIII Rx Only
10702-040-102024-04-11C16284748780-11030e365-3875-111a-e063-dadaa90a10e2Benzphetamine Hydrochloride Tablets CIII Rx Only
10702-040-502024-04-11C16284748780-11030e365-3875-111a-e063-dadaa90a10e2Benzphetamine Hydrochloride Tablets CIII Rx Only
10702-040-012024-01-30C16284748780-11030e365-3875-111a-e063-dadaa90a10e2Benzphetamine Hydrochloride Tablets CIII Rx Only
10702-040-032024-01-30C16284748780-11030e365-3875-111a-e063-dadaa90a10e2Benzphetamine Hydrochloride Tablets CIII Rx Only
10702-040-102024-01-30C16284748780-11030e365-3875-111a-e063-dadaa90a10e2Benzphetamine Hydrochloride Tablets CIII Rx Only
10702-040-502024-01-30C16284748780-11030e365-3875-111a-e063-dadaa90a10e2Benzphetamine Hydrochloride Tablets CIII Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10702-040-01BENZPHETAMINE HYDROCHLORIDE100 in 1 BOTTLETABLET1009
10702-040-03BENZPHETAMINE HYDROCHLORIDE30 in 1 BOTTLETABLET309
10702-040-10BENZPHETAMINE HYDROCHLORIDE1000 in 1 BOTTLETABLET10009
10702-040-50BENZPHETAMINE HYDROCHLORIDE500 in 1 BOTTLETABLET5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-040-01EA - Each10702-0405748339c-df30-4d23-a1c4-1694ac4d7eae12012-07-24
10702-040-03EA - Each10702-040caee5377-2bf9-40a0-b67d-9c3929eb70fe12012-07-24
10702-040-50EA - Each10702-040ae2db329-b758-4e62-88c8-efb21161862212012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-040BENZPHETAMINE HYDROCHLORIDE TABLET [KVK-TECH, INC]9Current NDC, Legacy NDC, 4 package rows20240413_14d4589d-7f1c-4b6e-9557-59dad39b0960.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904368benzphetamine HCl 50 MG Oral TabletPSN2b7014af-0cc9-4199-90f2-ec07ac02f8cf25
904368benzphetamine hydrochloride 50 MG Oral TabletSCD2b7014af-0cc9-4199-90f2-ec07ac02f8cf25
904368benzphetamine HCl 50 MG Oral TabletPSN1c726aa7-3b78-45de-aca0-fd8a5fff940310
904368benzphetamine hydrochloride 50 MG Oral TabletSCD1c726aa7-3b78-45de-aca0-fd8a5fff940310
904368benzphetamine HCl 50 MG Oral TabletPSN14d4589d-7f1c-4b6e-9557-59dad39b09609
904368benzphetamine hydrochloride 50 MG Oral TabletSCD14d4589d-7f1c-4b6e-9557-59dad39b09609
904368benzphetamine HCl 50 MG Oral TabletPSNf5c3c2ed-54a2-1def-e053-2995a90ab4e32
904368benzphetamine hydrochloride 50 MG Oral TabletSCDf5c3c2ed-54a2-1def-e053-2995a90ab4e32
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-040-0110702004001100 TABLET in 1 BOTTLE (10702-040-01) 100 tablet2010-07-210000-00-00NoNoCurrent
10702-040-031070200400330 TABLET in 1 BOTTLE (10702-040-03) 30 tablet2010-07-210000-00-00NoNoCurrent
10702-040-10107020040101000 TABLET in 1 BOTTLE (10702-040-10) 1000 tablet2010-07-210000-00-00NoNoCurrent
10702-040-5010702004050500 TABLET in 1 BOTTLE (10702-040-50) 500 tablet2010-07-210000-00-00NoNoCurrent