FDA.reportPublic FDA data

Benzphetamine Hydrochloride

Product NDC
53217-175
11-digit product format
532170175
Labeler code
53217
Product ID
53217-175_3904530d-83e6-4359-b6a9-63f15b0366f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzphetamine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA040747
Marketing category
ANDA
Marketing start
2010-09-07
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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-175-072020-01-31C16284748780-19d75b9d0-9d42-f424-e053-dadaa90a57ceRx Only
53217-175-142020-01-31C16284748780-19d75b9d0-9d42-f424-e053-dadaa90a57ceRx Only
53217-175-212020-01-31C16284748780-19d75b9d0-9d42-f424-e053-dadaa90a57ceRx Only
53217-175-422020-01-31C16284748780-19d75b9d0-9d42-f424-e053-dadaa90a57ceRx Only
53217-175-842020-01-31C16284748780-19d75b9d0-9d42-f424-e053-dadaa90a57ceRx Only
53217-175-902020-01-31C16284748780-19d75b9d0-9d42-f424-e053-dadaa90a57ceRx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-175-07Benzphetamine Hydrochloride7 in 1 BOTTLETABLET71
53217-175-14Benzphetamine Hydrochloride14 in 1 BOTTLETABLET141
53217-175-21Benzphetamine Hydrochloride21 in 1 BOTTLETABLET211
53217-175-42Benzphetamine Hydrochloride42 in 1 BOTTLETABLET421
53217-175-84Benzphetamine Hydrochloride84 in 1 BOTTLETABLET841
53217-175-90Benzphetamine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-175-07EA - Each53217-175658aa36c-5d8d-4589-9e8a-41074a318af412016-12-07
53217-175-14EA - Each53217-1753108b0a1-ac54-450c-9a67-3715d5165e7912016-12-07
53217-175-21EA - Each53217-1757d5247e2-0a9d-4f49-a8a3-df643715ae5412016-12-07
53217-175-42EA - Each53217-175ec48eb9c-6654-4e29-8a01-89eb152c0ad912016-12-07
53217-175-84EA - Each53217-175688f086e-dba0-45c7-acd6-0fb85965b0e912016-12-07
53217-175-90EA - Each53217-17566a81cb5-68b2-4f79-9a68-395eeaf81e4e12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-175BENZPHETAMINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 6 package rows20161206_5ca0eee3-8f84-4ee2-b339-c9cdbf6ffd52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904368benzphetamine HCl 50 MG Oral TabletPSN5ca0eee3-8f84-4ee2-b339-c9cdbf6ffd521
904368benzphetamine hydrochloride 50 MG Oral TabletSCD5ca0eee3-8f84-4ee2-b339-c9cdbf6ffd521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-175-07532170175077 in 1 BOTTLEHistorical
53217-175-145321701751414 in 1 BOTTLEHistorical
53217-175-215321701752121 in 1 BOTTLEHistorical
53217-175-425321701754242 in 1 BOTTLEHistorical
53217-175-845321701758484 in 1 BOTTLEHistorical
53217-175-905321701759090 in 1 BOTTLEHistorical