DEXTROAMPHETAMINE SULFATE

Product NDC
63629-2375
11-digit product format
636292375
Labeler code
63629
Product ID
63629-2375_8f8d027a-8618-467f-8f09-e120ee4521c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dextroamphetamine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210059
Marketing category
ANDA
Marketing start
2018-07-04
Substance
DEXTROAMPHETAMINE SULFATE
Active strength
5 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], 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
JJ768O327NDEXTROAMPHETAMINE SULFATE51-63-8DEXTROAMPHETAMINE SULFATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-2375-163629237501100 TABLET in 1 BOTTLE (63629-2375-1) 100 tablet2018-07-04NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Dextroamphetamine Sulfate Tablets, USP CII Rx onlyBryant Ranch Prepack2025-01-23HUMAN PRESCRIPTION DRUG LABEL106