Home NDC 63629-2107 Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate ER
Product NDC 63629-2107
11-digit product format 636292107
Labeler code 63629
Product ID 63629-2107_8988345e-d1ee-49d3-8da4-1eff727d2965
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate ER
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA206159
Marketing category ANDA
Marketing start 2019-06-25
Marketing end 0000-00-00
Substance AMPHETAMINE ASPARTATE; 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 63629-2107-1 63629210701 100 CAPSULE in 1 BOTTLE (63629-2107-1) 100 capsule 2021-02-15 0000-00-00 No No Current