17478-283 NDC - GENTAMICIN SULFATE

Drug Information

Product NDC: 17478-283

Proprietary Name: Gentamicin Sulfate

Non Proprietary Name: Gentamicin Sulfate

Active Ingredient(s):
  • 3 mg/mL GENTAMICIN SULFATE


Administration Route(s): OPHTHALMIC

Dosage Form(s): SOLUTION/ DROPS

Pharmacy Class(es):
  • Aminoglycoside Antibacterial [EPC];
  • Aminoglycosides [CS]

Labeler Information

Labeler Name: Akorn, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA064163
Marketing Category: ANDA
Start Marketing Date:12/13/2006

Package Information

No. Package Code Package Description Billing Unit
117478-283-101 BOTTLE, DROPPER in 1 CARTON (17478-283-10) > 5 mL in 1 BOTTLE, DROPPERML

NDC Record

Field Name Field Value Definition
PRODUCT NDC17478-283The 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 NAMEGentamicin SulfateThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEGentamicin SulfateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOLUTION/ DROPSThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEOPHTHALMICThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE12/13/2006This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct 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 NUMBERANDA064163This 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 NAMEAkorn, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEGENTAMICIN SULFATEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH3 
ACTIVE INGRED UNITmg/mL 
PHARM CLASSESAminoglycoside Antibacterial [EPC],Aminoglycosides [CS] 

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This page was last updated on: 11/18/2019