NDC 72189-036 Erythromycin

Erythromycin

NDC Product Code 72189-036

NDC CODE: 72189-036

Proprietary Name: Erythromycin What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Erythromycin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat certain eye infections (such as conjunctivitis). It is also used to prevent certain eye infections in newborns. It belongs to a class of drugs known as macrolide antibiotics. Erythromycin works by stopping the growth of bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

NDC Code Structure

NDC 72189-036-35

Package Description: 1 g in 1 TUBE

NDC Product Information

Erythromycin with NDC 72189-036 is a a human prescription drug product labeled by Direct_rx. The generic name of Erythromycin is erythromycin. The product's dosage form is ointment and is administered via ophthalmic form.

Labeler Name: Direct_rx

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Prescription Drug What 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.

Erythromycin Active Ingredient(s)

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

  • ERYTHROMYCIN 5 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • PETROLATUM (UNII: 4T6H12BN9U)
  • MINERAL OIL (UNII: T5L8T28FGP)

Administration Route(s)

What 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.
  • Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

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

  • Decreased Sebaceous Gland Activity - [PE] (Physiologic Effect)
  • Macrolide - [EPC] (Established Pharmacologic Class)
  • Macrolide Antimicrobial - [EPC] (Established Pharmacologic Class)
  • Macrolides - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Direct_rx
Labeler Code: 72189
FDA Application Number: ANDA062447 What 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. What 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: 10-08-2019 What 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 What 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 What 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

Erythromycin Ophthalmic

Erythromycin Ophthalmic is pronounced as (e rith'' roe mye' sin)

Why is erythromycin ophthalmic medication prescribed?
Ophthalmic erythromycin is used to treat bacterial infections of the eye. This medication is also used to prevent bacterial infections of the eye in newborn babies. Eryth...
[Read More]

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Erythromycin Product Label Images

Erythromycin 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

Erythromycin Ophthalmic Ointment belongs to the macrolide group of antibiotics. It is basic and readily forms a salt when combined with an acid. The base, as crystals or powder, is slightly soluble in water, moderately soluble in ether, and readily soluble in alcohol or chloroform. Erythromycin ((3R*,4S*,5S*,6R*,7R*,9R*,11R*,12R*,13S*,14R*)-4-[(2,6-dideoxy-3-C-methyl-3-0-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione) is antibiotic produced from a strain of Streptomyces erythraeus. It has the following structural formula:[Structure Image]Each gram contains Erythromycin USP 5 mg in a sterile ophthalmic base of mineral oil and white petrolatum.

Clinical Pharmacology

Microbiology:Erythromycin inhibits protein synthesis without affecting nucleic acid synthesis. Erythromycin is usually active against the following organisms in vitro and in clinical infections:Streptococcus pyogenes (group A ß-hemolytic)Alpha-hemolytic streptococci (viridans group)Staphylococcus aureus, including penicillinase-producing strains (methicillin-resistant staphylococci are uniformly resistant to erythromycin)Streptococcus pneumoniaMycoplasma pneumoniae (Eaton Agent, PPLO)Haemophilus influenzae (not all strains of this organism are susceptible at the erythromycin concentrations ordinarily achieved)Treponema pallidumCorynebacterium diphtheriaeNeisseria gonorrhoeaeChlamydia trachomatis

Indications & Usage

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin.For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeae or C. trachomatis. The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrheae is not established.For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants.

Contraindications

This drug is contraindicated in patients with a history of hypersensitivity to erythromycin.

Precautions

General:The use of antimicrobial agents may be associated with the overgrowth of nonsusceptible organisms including fungi; in such a case, antibiotic administration should be stopped and appropriate measures taken.Information for Patients:Avoid contaminating the applicator tip with material from the eye, fingers, or other source.Carcinogenesis, Mutagenesis, Impairment of Fertility:Two year oral studies conducted in rats with erythromycin did not provide evidence of tumorigenicity. Mutagenicity studies have not been conducted.No evidence of impaired fertility that appeared related to erythromycin was reported in animal studies.Pregnancy:Teratogenic effects -Pregnancy Category B.Reproduction studies have been performed in rats, mice, and rabbits using erythromycin and its various salts and esters, at doses that were several multiples of the usual human dose. No evidence of harm to the fetus that appeared related to erythromycin was reported in these studies. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, the erythromycins should be used during pregnancy only if clearly needed.Nursing Mothers:Caution should be exercised when erythromycin is administered to a nursing woman.Pediatric Use:See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.

Adverse Reactions

The most frequently reported adverse reactions are minor ocular irritations, redness, and hypersensitivity reactions.To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dosage & Administration

In the treatment of superficial ocular infections, a ribbon approximately 1 cm in length of Erythromycin Ophthalmic Ointment should be applied directly to the infected structure up to 6 times daily, depending on the severity of the infection. For prophylaxis of neonatal gonococcal or chlamydial conjunctivitis, a ribbon of ointment approximately 1 cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed from the eye following instillation. A new tube should be used for each infant.

How Supplied

Sterile Erythromycin Ophthalmic Ointment USP, 5 mg/g as follows:3.5 g (1/8 oz) tamper-evident tubes 24 x 3.5 g (1/8 oz) Hospital-Pak (for hospital use only) Carton of fifty (50) Unit Dose 1 g tubes NDC 0574-4024-50Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat.Protect from freezing.

Other

Manufactured ForPerrigo®Minneapolis, MN 55427SW700 RC J1 Rev 09-13 AR1013Ini 0813

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