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0409-3301 NDC - PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE)

Drug Information

Product NDC: 0409-3301

Proprietary Name: Precedex

Non Proprietary Name: DEXMEDETOMIDINE HYDROCHLORIDE

Active Ingredient(s):
  • 4 ug/mL DEXMEDETOMIDINE HYDROCHLORIDE


Administration Route(s): INTRAVENOUS

Dosage Form(s): INJECTION, SOLUTION

Pharmacy Class(es):
  • Adrenergic alpha2-Agonists [MoA];
  • Central alpha-2 Adrenergic Agonist [EPC];
  • General Anesthesia [PE]

Labeler Information

Labeler Name: Hospira, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA021038
Marketing Category: NDA
Start Marketing Date:3/7/2022

Package Information

No. Package Code Package Description Billing Unit
10409-3301-1010 VIAL in 1 CARTON (0409-3301-10) > 20 mL in 1 VIAL (0409-3301-01)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0409-3301The 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 NAMEPrecedexThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEDEXMEDETOMIDINE HYDROCHLORIDEThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAVENOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE3/7/2022This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct 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.
APPLICATION NUMBERNDA021038This 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.
LABELER NAMEHospira, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEDEXMEDETOMIDINE HYDROCHLORIDEAn 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 STRENGTH4 
ACTIVE INGRED UNITug/mL 
PHARM CLASSESAdrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE] 

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