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 Field Definition
1 PRODUCT NDC 24338-853 The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
2 PRODUCT TYPE NAME HUMAN PRESCRIPTION DRUG Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
3 PROPRIETARY NAME Zenzedi Also known as the trade name. It is the name of the product chosen by the labeler.
4 NON PROPRIETARY NAME Dextroamphetamine Sulfate Sometimes called the generic name, this is usually the active ingredient(s) of the product.
5 DOSAGE FORM NAME TABLET The translation of the DosageForm Code submitted by the firm.
6 ROUTE NAME ORAL The translation of the Route Code submitted by the firm, indicating route of administration.
7 START MARKETING DATE 5/31/2013 This is the date that the labeler indicates was the start of its marketing of the drug product.
8 MARKETING CATEGORY NAME ANDA Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
9 APPLICATION NUMBER ANDA090533 This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
10 LABELER NAME Arbor Pharmaceuticals, Inc. Name of Company corresponding to the labeler code segment of the Product NDC.
11 SUBSTANCE NAME DEXTROAMPHETAMINE SULFATE This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
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 This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

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This page was last updated on: 4/21/2015