DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE

Product NDC
60687-644
11-digit product format
606870644
Labeler code
60687
Product ID
60687-644_ded76950-977c-7116-e053-2a95a90aa0b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA213709
Marketing category
ANDA
Marketing start
2022-05-25
Marketing end
0000-00-00
Substance
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength
3 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-644-25EA - Each60687-644b1aec5ae-6cd4-4e6a-bc5d-17610337b15412022-08-04
60687-644-95EA - Each60687-64422ca847f-1d8e-48d9-806b-1d28237318ad12022-08-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-644-256068706442530 BLISTER PACK in 1 CARTON (60687-644-25) > 1 TABLET in 1 BLISTER PACK (60687-644-95) 30 blister pack2022-05-250000-00-00NoNoCurrent