Home NDC 71335-1038 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Product NDC 71335-1038
11-digit product format 713351038
Labeler code 71335
Product ID 71335-1038_0540ca26-007e-47f9-9301-4e5488f1ea49
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA040439
Marketing category ANDA
Marketing start 2002-06-14
Marketing end 0000-00-00
Substance AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength 8 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 71335-1038-1 71335103801 60 TABLET in 1 BOTTLE (71335-1038-1) 60 tablet 2022-03-16 0000-00-00 No No Current 71335-1038-2 71335103802 90 TABLET in 1 BOTTLE (71335-1038-2) 90 tablet 2022-03-16 0000-00-00 No No Current 71335-1038-3 71335103803 30 TABLET in 1 BOTTLE (71335-1038-3) 30 tablet 2022-03-16 0000-00-00 No No Current