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0485-0082 NDC - ED-SPAZ (HYOSCYAMINE SULFATE)

Drug Information

Product NDC: 0485-0082

Proprietary Name: ED-SPAZ

Non Proprietary Name: HYOSCYAMINE SULFATE

Active Ingredient(s):
  • .125 mg/1 HYOSCYAMINE SULFATE


Administration Route(s): ORAL

Dosage Form(s): TABLET, ORALLY DISINTEGRATING

Labeler Information

Labeler Name: EDWARDS PHARMACEUTICALS, INC.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:5/12/2010

Package Information

No. Package Code Package Description Billing Unit
10485-0082-01100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0485-0082-01)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0485-0082The 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.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates 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.
PROPRIETARY NAMEED-SPAZThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEHYOSCYAMINE SULFATEThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, ORALLY DISINTEGRATINGThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE5/12/2010This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED DRUG OTHERProduct 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.
LABELER NAMEEDWARDS PHARMACEUTICALS, INC.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEHYOSCYAMINE SULFATEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH.125 
ACTIVE INGRED UNITmg/1 

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This page was last updated on: 11/10/2022