Home NDC 43602-320 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Product NDC 43602-320
11-digit product format 436020320
Labeler code 43602
Product ID 43602-320_d83a3b23-e47e-4f28-9e87-8a0a7e1b127a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Ascent Pharmaceuticals, Inc
Application ANDA214959
Marketing category ANDA
Marketing start 2021-09-29
Marketing end 0000-00-00
Substance DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE
Active strength 6 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule CII
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43602-320 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ASCENT PHARMACEUTICALS, INC] 2 Legacy NDC 20211008_d91c8624-8002-4f03-ad26-deb195be4e09.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 43602-320-05 43602032005 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43602-320-05) 2021-09-29 0000-00-00 No No Current 43602-320-30 43602032030 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43602-320-30) 2021-09-29 0000-00-00 No No Current