FDA.reportPublic FDA data

BENZPHETAMINE HYDROCHLORIDE

Product NDC
71335-0451
11-digit product format
713350451
Labeler code
71335
Product ID
71335-0451_98aa03d7-8df0-4b01-8371-9761a0176afa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzphetamine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0451-1BENZPHETAMINE HYDROCHLORIDE30 in 1 BOTTLETABLET3010
71335-0451-2BENZPHETAMINE HYDROCHLORIDE7 in 1 BOTTLETABLET710
71335-0451-3BENZPHETAMINE HYDROCHLORIDE14 in 1 BOTTLETABLET1410
71335-0451-4BENZPHETAMINE HYDROCHLORIDE21 in 1 BOTTLETABLET2110
71335-0451-5BENZPHETAMINE HYDROCHLORIDE42 in 1 BOTTLETABLET4210
71335-0451-6BENZPHETAMINE HYDROCHLORIDE84 in 1 BOTTLETABLET8410
71335-0451-7BENZPHETAMINE HYDROCHLORIDE60 in 1 BOTTLETABLET6010
71335-0451-8BENZPHETAMINE HYDROCHLORIDE90 in 1 BOTTLETABLET9010
71335-0451-9BENZPHETAMINE HYDROCHLORIDE120 in 1 BOTTLETABLET12010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0451BENZPHETAMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 9 package rows20240601_1c726aa7-3b78-45de-aca0-fd8a5fff9403.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904368benzphetamine HCl 50 MG Oral TabletPSN1c726aa7-3b78-45de-aca0-fd8a5fff940310
904368benzphetamine hydrochloride 50 MG Oral TabletSCD1c726aa7-3b78-45de-aca0-fd8a5fff940310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0451-17133504510130 TABLET in 1 BOTTLE (71335-0451-1) 30 tablet2018-08-170000-00-00NoNoCurrent
71335-0451-2713350451027 TABLET in 1 BOTTLE (71335-0451-2) 7 tablet2018-07-250000-00-00NoNoCurrent
71335-0451-37133504510314 TABLET in 1 BOTTLE (71335-0451-3) 14 tablet2018-07-250000-00-00NoNoCurrent
71335-0451-47133504510421 TABLET in 1 BOTTLE (71335-0451-4) 21 tablet2018-09-140000-00-00NoNoCurrent
71335-0451-57133504510542 TABLET in 1 BOTTLE (71335-0451-5) 42 tablet2018-04-230000-00-00NoNoCurrent
71335-0451-67133504510684 TABLET in 1 BOTTLE (71335-0451-6) 84 tablet2024-05-290000-00-00NoNoCurrent
71335-0451-77133504510760 TABLET in 1 BOTTLE (71335-0451-7) 60 tablet2018-07-100000-00-00NoNoCurrent
71335-0451-87133504510890 TABLET in 1 BOTTLE (71335-0451-8) 90 tablet2018-02-120000-00-00NoNoCurrent
71335-0451-971335045109120 TABLET in 1 BOTTLE (71335-0451-9) 120 tablet2018-05-290000-00-00NoNoCurrent