DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE

Product NDC
72162-2251
11-digit product format
721622251
Labeler code
72162
Product ID
72162-2251_00fbb464-2fa5-4be2-b904-9b357fbf90d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209799
Marketing category
ANDA
Marketing start
2018-07-04
Substance
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength
5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
O1ZPV620O4AMPHETAMINE ASPARTATE MONOHYDRATE851591-76-9AMPHETAMINE ASPARTATE MONOHYDRATE
6DPV8NK46SAMPHETAMINE SULFATE60-13-9AMPHETAMINE SULFATE
G83415V073DEXTROAMPHETAMINE SACCHARATE350708-40-6DEXTROAMPHETAMINE SACCHARATE
JJ768O327NDEXTROAMPHETAMINE SULFATE51-63-8DEXTROAMPHETAMINE SULFATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2251-172162225101100 TABLET in 1 BOTTLE (72162-2251-1) 100 tablet2024-02-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DEXTROAMPHETAMINE SACCHARATEBryant Ranch Prepack2024-02-08HUMAN PRESCRIPTION DRUG LABEL100