DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE

Product NDC
63629-2379
11-digit product format
636292379
Labeler code
63629
Product ID
63629-2379_0a5e1a6a-7c20-4cdc-a2f0-75f431f24f18
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
Marketing end
0000-00-00
Substance
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength
1 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
2023-12-31
Current FDA listing
Historical FDA.report record

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 startMarketing endSampleExclude flagStatus
63629-2379-163629237901100 TABLET in 1 BOTTLE (63629-2379-1) 100 tablet2021-02-220000-00-00NoNoCurrent