76329-3301 NDC - DEXTROSE MONOHYDRATE

Drug Information

Product NDC: 76329-3301

Proprietary Name: Dextrose Monohydrate

Non Proprietary Name: Dextrose Monohydrate

Active Ingredient(s):
  • 500 mg/mL DEXTROSE MONOHYDRATE


Administration Route(s): PARENTERAL

Dosage Form(s): INJECTION

Labeler Information

Labeler Name: International Medication Systems, Limited
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:6/1/2000

Package Information

No. Package Code Package Description Billing Unit
176329-3301-11 SYRINGE in 1 CARTON (76329-3301-1) / 50 mL in 1 SYRINGEML

NDC Record

Field Name Field Value Definition
PRODUCT NDC76329-3301The 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 NAMEDextrose MonohydrateThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEDextrose MonohydrateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEPARENTERALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE6/1/2000This 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 NAMEInternational Medication Systems, LimitedName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEDEXTROSE MONOHYDRATEAn 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 STRENGTH500 
ACTIVE INGRED UNITmg/mL 

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This page was last updated on: 2/1/2023