NDC 24208-910 Erythromycin
Ointment Ophthalmic

Product Information

Product Code24208-910
Proprietary Name 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.
Erythromycin
Non-Proprietary Name 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.
Erythromycin
Product Type 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.
Human Prescription Drug
Dosage FormOintment - 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.
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.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Bausch & Lomb Incorporated
Labeler Code24208
FDA Application Number 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.
ANDA064067
Marketing Category 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.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
07-29-1994
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Packages

NDC 24208-910-19

Package Description: 50 TUBE in 1 BOX > 1 g in 1 TUBE

Price per Unit: $5.35984 per GM

NDC 24208-910-55

Package Description: 1 TUBE in 1 CARTON > 3.5 g in 1 TUBE

Price per Unit: $2.72308 per GM

Product Details

Erythromycin is a human prescription drug product labeled by Bausch & Lomb Incorporated. The product's dosage form is ointment and is administered via ophthalmic form.


What are Erythromycin Active Ingredients?

The following is the list of active ingredients in this product. An 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.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


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)


Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.


* Please review the disclaimer below.

Patient Education

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]

* Please review the disclaimer below.

Erythromycin Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Rx only


Description



Erythromycin Ophthalmic Ointment, USP belongs to the macrolide group of antibiotics. The sterile ophthalmic ointment flows freely over the conjunctiva. Erythromycin base, as crystals or powder, is slightly soluble in water, moderately soluble in ether, and readily soluble in alcohol or chloroform. Erythromycin is an antibiotic produced from a strain of Streptomyces erythraeus. It is basic and readily forms a salt when combined with an acid. It has the following structural formula:

C37H67NO13

Mol. Wt. 733.94

Chemical Name: (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)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2, 10-dione

Each Gram Contains: ACTIVE: Erythromycin, USP 5 mg (0.5%); INACTIVES: Mineral Oil, White Petrolatum.


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 β-hemolytic), Alpha-hemolytic streptococci (viridans group); Staphylococcus aureus, including penicillinase-producing strains (methicillin-resistant staphylococci are uniformly resistant to erythromycin); Streptococcus pneumoniae; Mycoplasma pneumoniae (Eaton Agent, PPLO); Haemophilus influenzae (not all strains of this organism are susceptible at the erythromycin concentrations ordinarily achieved); Treponema pallidum; Corynebacterium diphtheriae; Neisseria gonorrhoeae; Chlamydia trachomatis.


Indications And 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. gonorrhoeae 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.


General



The use of antimicrobial agents may be associated with the overgrowth of non-susceptible organisms including fungi; in such a case, antibiotic administration should be stopped and appropriate measures taken.


Information For Patients:



Avoid contaminating the tip of container 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 or harm to the fetus that appeared related to erythromycin was reported in these studies.


Pregnancy:



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. 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 Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


Dosage And Administration



In the treatment of superficial ocular infections, erythromycin ophthalmic ointment approximately 1 cm in length should be applied directly to the infected eye(s) up to six times daily, depending on the severity of the infection.

For prophylaxis of neonatal gonococcal or chlamydial ophthalmia, 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



Erythromycin Ophthalmic Ointment, USP 0.5% is available in the following sizes:

1/8 oz. (3.5 g) tamper-resistant tube - NDC 24208-910-55

DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.

1 g tin container (in cartons of 50) - NDC 24208-910-19

DO NOT USE IF BOTTOM RIDGE OF TUBE CAP IS EXPOSED.


Storage:



Store between 15°-25°C (59°-77°F).

KEEP OUT OF REACH OF CHILDREN.

Revised: July 2016

Bausch + Lomb, a division of
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
©Bausch & Lomb Incorporated

9043404 (Folded)
9043504 (Flat)


Package/Label Principal Display Panel



NDC 24208-910-55

Erythromycin
Ophthalmic
Ointment, USP
0.5% (Sterile)

FOR TOPICAL ADMINISTRATION
IN THE EYE

Rx only

Net wt. 1/8 oz (3.5 g)

BAUSCH + LOMB


* Please review the disclaimer below.