Home NDC 43602-988 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE
Product NDC 43602-988
11-digit product format 436020988
Labeler code 43602
Product ID 43602-988_5c2a8c35-d15b-44d5-8909-301221a1936c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Dosage form TABLET
Route ORAL
Labeler Ascent Pharmaceuticals, Inc.
Application ANDA213709
Marketing category ANDA
Marketing start 2021-04-22
Marketing end 0000-00-00
Substance AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE
Active strength 8 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 43602-988 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET [ASCENT PHARMACEUTICALS, INC.] 1 Legacy NDC 20210803_08085b56-d0e6-45af-9ea3-71c7996f750a.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43602-988-15 43602098815 100 TABLET in 1 BOTTLE (43602-988-15) 100 tablet 2021-04-22 0000-00-00 No No Current 43602-988-16 43602098816 500 TABLET in 1 BOTTLE (43602-988-16) 500 tablet 2021-04-22 0000-00-00 No No Current