Benzphetamine Hydrochloride

Product NDC
42806-081
11-digit product format
428060081
Labeler code
42806
Product ID
42806-081_b4e5d191-8cbf-4111-a07b-025b920269c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzphetamine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA090346
Marketing category
ANDA
Marketing start
2015-12-16
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
e1de3598-2dc1-55e2-fc07-ee2e74c73cfcProduct name320201013

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-081-01Benzphetamine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1008
42806-081-05Benzphetamine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5008
42806-081-30Benzphetamine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-081-01EA - Each42806-0819af027f1-e420-47a2-afc0-c5fdf5cba11c12016-09-02
42806-081-30EA - Each42806-081ee6613db-225a-4885-9c25-f88d13fca79f12016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-081BENZPHETAMINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]8Current NDC, Legacy NDC, 3 package rows20231228_f6d9b369-4b64-4d3f-844d-5d60dd257c55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904368benzphetamine HCl 50 MG Oral TabletPSNf6d9b369-4b64-4d3f-844d-5d60dd257c558
904368benzphetamine hydrochloride 50 MG Oral TabletSCDf6d9b369-4b64-4d3f-844d-5d60dd257c558

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42806-081-0142806008101100 TABLET, FILM COATED in 1 BOTTLE (42806-081-01) 2015-12-160000-00-00NoNoCurrent
42806-081-0542806008105500 TABLET, FILM COATED in 1 BOTTLE (42806-081-05) 2015-12-160000-00-00NoNoCurrent
42806-081-304280600813030 TABLET, FILM COATED in 1 BOTTLE (42806-081-30) 2015-12-160000-00-00NoNoCurrent