Home NDC 16714-951 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Product NDC 16714-951
11-digit product format 167140951
Labeler code 16714
Product ID 16714-951_70c31517-778a-4dbb-8cf2-ede48bffff2e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Dosage form TABLET
Route ORAL
Labeler NorthStar RxLLC
Application ANDA202424
Marketing category ANDA
Marketing start 2019-03-20
Marketing end 0000-00-00
Substance AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength 3 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 2024-12-31
Current FDA listing Historical FDA.report record DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-951 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [NORTHSTAR RXLLC] 6 Legacy NDC 20240719_8468623b-9584-43ef-ac16-fc15b060624c.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16714-951-01 16714095101 100 TABLET in 1 BOTTLE (16714-951-01) 100 tablet 2019-03-20 0000-00-00 No No Current