76420-104 NDC - NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE)

Drug Information

  • Product NDC: 76420-104
  • Proprietary Name: Neomycin and Polymyxin B Sulfates and Hydrocortisone
  • Non Proprietary Name: Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
  • Active Ingredient(s): 10 mg/mL HYDROCORTISONE; 3.5 mg/mL NEOMYCIN SULFATE; 10000 [USP'U]/mL POLYMYXIN B SULFATE
  • Administration Route(s): AURICULAR (OTIC)
  • Dosage Form(s): SOLUTION/ DROPS
  • Pharmacy Class(es): Aminoglycoside Antibacterial [EPC]; Aminoglycosides [CS]; Corticosteroid Hormone Receptor Agonists [MoA]; Corticosteroid [EPC]; Polymyxin-class Antibacterial [EPC]; Polymyxins [CS]

Labeler Information

Field Name Field Value
Labeler Name: Asclemed USA, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA064053
Marketing Category: ANDA
Start Marketing Date:12/29/1995

Package Information

No. Package Code Package Description Billing Unit
176420-104-1010 mL in 1 BOTTLE, DROPPER (76420-104-10)

NDC Record

Field Name Field Value Definition
PRODUCT NDC76420-104This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGThis 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.
PROPRIETARY NAMENeomycin and Polymyxin B Sulfates and HydrocortisoneThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMENeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneThe 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 NAMEAURICULAR (OTIC)The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE12/29/1995This 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 NUMBERANDA064053This 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 NAMEAsclemed USA, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEHYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B 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 STRENGTH10; 3.5; 10000 
ACTIVE INGRED UNITmg/mL; mg/mL; [USP'U]/mL 
PHARM CLASSESAminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS] 

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This page was last updated on: 12/6/2025

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