NDC 61919-918 Gentamicin Sulfate

Gentamicin Sulfate

NDC Product Code 61919-918

NDC Product Information

Gentamicin Sulfate with NDC 61919-918 is a a human prescription drug product labeled by Direct Rx. The generic name of Gentamicin Sulfate is gentamicin sulfate. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Direct Rx

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

Product Type: Human Prescription Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates 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.


Gentamicin Sulfate Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • GENTAMICIN SULFATE 3 mg/mL

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

Additional informationCallout TooltipWhat is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Aminoglycoside Antibacterial - [EPC] (Established Pharmacologic Class)
  • Aminoglycosides - [CS]

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Direct Rx
Labeler Code: 61919
FDA Application Number: ANDA064163 Additional informationCallout TooltipWhat is the FDA Application Number?
This 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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. Additional informationCallout TooltipWhat is the Marketing Category?
Product 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.

Start Marketing Date: 03-19-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Gentamicin Ophthalmic

Gentamicin Ophthalmic is pronounced as (jen ta mye' sin)

Why is gentamicin ophthalmic medication prescribed?
Ophthalmic gentamicin is used to treat certain eye infections. Gentamicin is in a class of medications called antibiotics. It works by killing the bacteria that cause inf...
[Read More]

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Gentamicin Sulfate Product Label Images

Gentamicin Sulfate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description Section

Gentamicin sulfate ophthalmic solution, USP is a sterile, topical anti-infective agent for ophthalmic use.Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C1, C2, and C1A. All three components appear to have similar antimicrobial activity. Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as followsEach mL contains: Active: gentamicin sulfate equivalent to 3 mg (0.3%) gentamicin base. Preservative: benzalkonium chloride. Inactives: edetate disodium; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; and hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The solution is an aqueous, buffered solution with a shelf life pH range of 6.5 to 7.5.

Clinical Pharmacology Section

MicrobiologyGentamicin sulfate is active in vitro against many strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

Indications & Usage Section

Gentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

Contraindications Section

Gentamicin sulfate ophthalmic solution, USP is contraindicated in patients with known hypersensitivity to any of its components.

Warnings Section

NOT FOR INJECTION INTO THE EYE.Gentamicin sulfate ophthalmic solution, USP is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.

Precautions Section

GeneralProlonged use of topical antibiotics may give rise to overgrowth of nonsusceptible microorganisms, including fungi. Bacterial resistance to gentamicin may also develop. If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.If irritation or hypersensitivity to any component of the drug develops, the patient should discontinue use of this preparation and appropriate therapy should be instituted.Information for PatientsTo avoid contamination, do not touch tip of container to the eye, eyelid or any surface.Carcinogenesis, Mutagenesis, Impairment of FertilityThere are no published carcinogenicity or impairment of fertility studies on gentamicin. Aminoglycoside antibiotics have been found to be non-mutagenic.PregnancyPregnancy Category CGentamicin has been shown to depress body weights, kidney weights and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose. There are no adequate and well-controlled studies in pregnant women. Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Pediatric UseSafety and effectiveness in neonates have not been established

Adverse Reactions Section

Bacterial and fungal corneal ulcers have developed during treatment with gentamicin ophthalmic preparations.The most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non-specific conjunctivitis, conjunctival epithelial defects and conjunctival hyperemia.Other adverse reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura and hallucinations.

Dosage & Administration Section

Instill one or two drops into the affected eye(s) every four hours. In severe infections, dosage may be increased to as much as two drops every hour.

How Supplied Section

Gentamicin sulfate ophthalmic solution, USP 0.3% is supplied sterile in white opaque LDPE plastic bottles and tips with white high impact polystyrene (HIPS) caps as follows:            5 mL in 10 mL bottle – NDC 60758-188-05Storage: Store at or below 25°C (77°F). Avoid exposure to excessive heat (40°C/104°F or above).Revised: 08/2013© 2013 Allergan, Inc.Irvine, CA 92612, U.S.A.® mark owned by Allergan, Inc.Made in the U.S.A.

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