Amphetamine Sulfate

Product NDC
57664-075
11-digit product format
576640075
Labeler code
57664
Product ID
57664-075_278f897d-b963-43a5-ae16-58267d1aecd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amphetamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA214574
Marketing category
ANDA
Marketing start
2021-01-27
Marketing end
0000-00-00
Substance
AMPHETAMINE SULFATE
Active strength
10 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-075-88EA - Each57664-0756b52e331-be53-46dd-a823-baf8a38efaf012021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-075AMPHETAMINE SULFATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]4Legacy NDC20250522_8fa41f19-0b2b-4b6a-aa5f-d28f8213a6bc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-075-8857664007588100 TABLET in 1 BOTTLE (57664-075-88) 100 tablet2021-01-270000-00-00NoNoCurrent