24338-853 NDC - ZENZEDI (DEXTROAMPHETAMINE SULFATE)

Drug Information

Product NDC: 24338-853

Proprietary Name: Zenzedi

Non Proprietary Name: Dextroamphetamine Sulfate

Active Ingredient(s):
  • 10 mg/1 DEXTROAMPHETAMINE SULFATE


Administration Route(s): ORAL

Dosage Form(s): TABLET

Pharmacy Class(es):
  • Central Nervous System Stimulant [EPC];
  • Central Nervous System Stimulation [PE]

Labeler Information

Labeler Name: Arbor Pharmaceuticals, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA090533
Marketing Category: ANDA
Start Marketing Date:5/31/2013
DEA Schedule:CII

Package Information

No. Package Code Package Description
1 24338-853-10 100 TABLET in 1 BOTTLE (24338-853-10)

NDC Record

No. Field Name Field Value
1 PRODUCT NDC 24338-853
2 PRODUCT TYPE NAME HUMAN PRESCRIPTION DRUG
3 PROPRIETARY NAME Zenzedi
4 NON PROPRIETARY NAME Dextroamphetamine Sulfate
5 DOSAGE FORM NAME TABLET
6 ROUTE NAME ORAL
7 START MARKETING DATE 5/31/2013
8 MARKETING CATEGORY NAME ANDA
9 APPLICATION NUMBER ANDA090533
10 LABELER NAME Arbor Pharmaceuticals, Inc.
11 SUBSTANCE NAME DEXTROAMPHETAMINE SULFATE
12 ACTIVE NUMERATOR STRENGTH 10
13 ACTIVE INGRED UNIT mg/1
14 PHARM CLASSES Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
15 DEA SCHEDULE CII

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This page was last updated on: 9/18/2014