benzphetamine hydrochloride

Product NDC
46672-843
11-digit product format
466720843
Labeler code
46672
Product ID
46672-843_a4083a27-aa97-6830-e053-2a95a90aeda2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzphetamine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mikart, LLC
Application
ANDA090473
Marketing category
ANDA
Marketing start
2010-09-15
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
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090473-001BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-09-15
A090473-002BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2010-09-15

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A090473-002AA

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZPHETAMINE HYDROCHLORIDEACTIVE INGREDIENT43DWT87QT7BENZPHETAMINE HYDROCHLORIDE TABLET [MIKART, INC.]1
BENZPHETAMINEACTIVE MOIETY0M3S43XK27BENZPHETAMINE HYDROCHLORIDE TABLET [MIKART, INC.]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LBENZPHETAMINE HYDROCHLORIDE TABLET [MIKART, INC.]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BBENZPHETAMINE HYDROCHLORIDE TABLET [MIKART, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RBENZPHETAMINE HYDROCHLORIDE TABLET [MIKART, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBENZPHETAMINE HYDROCHLORIDE TABLET [MIKART, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46672-843-1046672084310100 TABLET in 1 BOTTLE, PLASTIC (46672-843-10) 100 tablet2010-09-150000-00-00NoNoCurrent
46672-843-644667208436414 TABLET in 1 BOTTLE, PLASTIC (46672-843-64) 14 tablet2010-09-150000-00-00NoNoCurrent