Drug Information

Product NDC: 53240-151

Proprietary Name: Zephrex-D

Non Proprietary Name: Pseudoephedrine Hydrochloride

Active Ingredient(s):

Administration Route(s): ORAL

Dosage Form(s): TABLET

Labeler Information

Labeler Name: Westport Pharmaceuticals
Product Type: HUMAN OTC DRUG
FDA Application Number: part341
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:11/15/2012

Package Information

No. Package Code Package Description
1 53240-151-01 24 TABLET in 1 PACKAGE (53240-151-01)

NDC Record

No. Field Name Field Value Field Definition
1 PRODUCT NDC 53240-151 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 OTC DRUG Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
3 PROPRIETARY NAME Zephrex-D The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
4 NON PROPRIETARY NAME Pseudoephedrine Hydrochloride The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
5 DOSAGE FORM NAME TABLET The translation of the dosage form 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 11/15/2012 This is the date that the labeler indicates was the start of its marketing of the drug product.
8 MARKETING CATEGORY NAME OTC MONOGRAPH FINAL 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 part341 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 Westport Pharmaceuticals Name of Company corresponding to the labeler code segment of the Product NDC.
11 SUBSTANCE NAME PSEUDOEPHEDRINE HYDROCHLORIDE This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

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This page was last updated on: 11/17/2017