Home NDC 0527-1505 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Product NDC 0527-1505
11-digit product format 005271505
Labeler code 0527
Product ID 0527-1505_c8e3e12d-63f1-451f-ab4e-51c7ec63cecf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Dosage form TABLET
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA211352
Marketing category ANDA
Marketing start 2018-12-12
Marketing end 0000-00-00
Substance AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength 5 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 Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0527-1505-37 00527150537 100 TABLET in 1 BOTTLE (0527-1505-37) 100 tablet 2018-12-12 0000-00-00 No No Current 0527-1505-41 00527150541 500 TABLET in 1 BOTTLE (0527-1505-41) 500 tablet 2018-12-12 0000-00-00 No No Current