Benzphetamine Hydrochloride

Product NDC
75834-100
11-digit product format
758340100
Labeler code
75834
Product ID
75834-100_103b4cf1-4b5d-44b3-89e2-a393ef4f2276
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzphetamine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA040747
Marketing category
ANDA
Marketing start
2016-01-15
Marketing end
0000-00-00
Substance
BENZPHETAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
DEA schedule
CIII
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e1de3598-2dc1-55e2-fc07-ee2e74c73cfcProduct name320201013

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75834-100-01Benzphetamine Hydrochloride100 in 1 BOTTLETABLET1001
75834-100-05Benzphetamine Hydrochloride500 in 1 BOTTLETABLET5001
75834-100-30Benzphetamine Hydrochloride30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-100-01EA - Each75834-1000fbbb140-b82e-4451-ae9b-cb80c4a837d012016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-100BENZPHETAMINE HYDROCHLORIDE TABLET [NIVAGEN PHARMACEUTICALS, INC.]1Legacy NDC, 3 package rows20160127_5f5b95b3-a18f-4289-b9a6-a3278ef5966d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904372benzphetamine HCl 25 MG Oral TabletPSN5f5b95b3-a18f-4289-b9a6-a3278ef5966d1
904368benzphetamine HCl 50 MG Oral TabletPSN5f5b95b3-a18f-4289-b9a6-a3278ef5966d1
904372benzphetamine hydrochloride 25 MG Oral TabletSCD5f5b95b3-a18f-4289-b9a6-a3278ef5966d1
904368benzphetamine hydrochloride 50 MG Oral TabletSCD5f5b95b3-a18f-4289-b9a6-a3278ef5966d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
75834-100-0175834010001100 in 1 BOTTLEHistorical
75834-100-0575834010005500 in 1 BOTTLEHistorical
75834-100-307583401003030 in 1 BOTTLEHistorical