Gentamicin Sulfate
Direct Rx
Human Prescription Drug
NDC 61919-918Gentamicin Sulfate is a human prescription drug labeled by 'Direct Rx'. National Drug Code (NDC) number for Gentamicin Sulfate is 61919-918. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Gentamicin Sulfate drug includes Gentamicin Sulfate - 3 mg/mL . The currest status of Gentamicin Sulfate drug is Active.
Drug Information:
| Drug NDC: | 61919-918 |
| The 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. |
| Proprietary Name: | Gentamicin Sulfate |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Gentamicin Sulfate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Direct Rx |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution/ Drops |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | GENTAMICIN SULFATE - 3 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | OPHTHALMIC
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 19 Mar, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 Dec, 2025 |
| This 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. |
| Application Number: | ANDA064163 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | DIRECT RX
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 310467
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UNII: | 8X7386QRLV
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Aminoglycoside Antibacterial [EPC]
Aminoglycosides [CS]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 61919-918-05 | 5 mL in 1 BOTTLE, DROPPER (61919-918-05) | 19 Mar, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Gentamicin sulfate gentamicin sulfate sodium phosphate, monobasic gentamicin sulfate gentamicin sodium phosphate, dibasic, anhydrous benzalkonium chloride sodium chloride gentamicin sulfate gentamicin sulfate edetate disodium polyvinyl alcohol water sodium chloride sodium phosphate, dibasic benzalkonium chloride hydrochloric acid sodium hydroxide gentamicin sulfate gentamicin
Indications and Usage:
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.
Warnings:
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.
Dosage and Administration:
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.
Contraindications:
Contraindications section gentamicin sulfate ophthalmic solution, usp is contraindicated in patients with known hypersensitivity to any of its components.
Adverse Reactions:
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.
Description:
Gentamicin sulfate is a water-soluble antibiotic of the aminoglycoside group. gentamicin sulfate ophthalmic solution is a sterile, aqueous solution for ophthalmic use. each ml contains: active: gentamicin sulfate usp (equivalent to 3 mg gentamicin base) preservative: benzalkonium chloride inactives: disodium phosphate, monosodium phosphate, and sodium chloride. the ph range is from 6.8 to 7.3. 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 activities. gentamicin sulfate occurs as a white powder and is soluble in water and insoluble in alcohol. the structural formula is as follows:
Clinical Pharmacology:
Clinical pharmacology section microbiology gentamicin 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.
How Supplied:
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 â ndc 60758-188-05 storage: 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.
Package Label Principal Display Panel:
Package label.principal display panel 918-05
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