FDA.reportPublic FDA data

BENZPHETAMINE HYDROCHLORIDE

Product NDC
43063-541
11-digit product format
430630541
Labeler code
43063
Product ID
43063-541_41393fbe-29e5-dd10-e063-6394a90a5a13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzphetamine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-541-14BENZPHETAMINE HYDROCHLORIDE14 in 1 BOTTLE, PLASTICTABLET1425
43063-541-30BENZPHETAMINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET3025
43063-541-45BENZPHETAMINE HYDROCHLORIDE45 in 1 BOTTLE, PLASTICTABLET4525
43063-541-60BENZPHETAMINE HYDROCHLORIDE60 in 1 BOTTLE, PLASTICTABLET6025
43063-541-90BENZPHETAMINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET9025
43063-541-98BENZPHETAMINE HYDROCHLORIDE120 in 1 BOTTLE, PLASTICTABLET12025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-541-14EA - Each43063-541fe42a4a6-7423-4790-beec-4f031cf0aee712014-11-05
43063-541-30EA - Each43063-5410c78b167-e84b-41e5-8e8b-294577ac945712014-11-05
43063-541-45EA - Each43063-541bd747408-002c-4d18-9c59-928988a6cf1d12016-03-04
43063-541-60EA - Each43063-541ec2978b1-2eb7-409a-9571-979488007b1f12020-05-08
43063-541-90EA - Each43063-541f395a546-aa9a-4d34-a78b-c26a40d119e512014-11-05
43063-541-98EA - Each43063-541dcaf14b1-7483-4fac-8b96-09ff8f6638b512019-09-05

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-541BENZPHETAMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]24Current NDC, Legacy NDC, 6 package rows20240809_2b7014af-0cc9-4199-90f2-ec07ac02f8cf.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-541-144306305411414 TABLET in 1 BOTTLE, PLASTIC (43063-541-14) 14 tablet2014-10-220000-00-00NoNoCurrent
43063-541-304306305413030 TABLET in 1 BOTTLE, PLASTIC (43063-541-30) 30 tablet2014-10-220000-00-00NoNoCurrent
43063-541-454306305414545 TABLET in 1 BOTTLE, PLASTIC (43063-541-45) 45 tablet2014-10-220000-00-00NoNoCurrent
43063-541-604306305416060 TABLET in 1 BOTTLE, PLASTIC (43063-541-60) 60 tablet2014-10-220000-00-00NoNoCurrent
43063-541-904306305419090 TABLET in 1 BOTTLE, PLASTIC (43063-541-90) 90 tablet2014-10-220000-00-00NoNoCurrent
43063-541-9843063054198120 TABLET in 1 BOTTLE, PLASTIC (43063-541-98) 120 tablet2010-07-210000-00-00NoNoCurrent