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NDC 76420-0212-30 Erythromycin 5 mg/g Details

Erythromycin 5 mg/g

Erythromycin is a OPHTHALMIC OINTMENT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Asclemed USA, Inc.. The primary component is ERYTHROMYCIN.

MedlinePlus Drug Summary

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. Erythromycin is in a class of medications called macrolide antibiotics. It works by killing bacteria that cause infections.

Related Packages: 76420-0212-30
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Erythromycin Ophthalmic

Product Information

NDC	76420-0212
Product ID	76420-212_d9ae93e7-f4a8-1df3-e053-2a95a90ae5b1
Associated GPIs	86101025004210
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Erythromycin
Proprietary Name Suffix	n/a
Non-Proprietary Name	Erythromycin
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	OINTMENT
Route	OPHTHALMIC
Active Ingredient Strength	5
Active Ingredient Units	mg/g
Substance Name	ERYTHROMYCIN
Labeler Name	Asclemed USA, Inc.
Pharmaceutical Class	Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA064030
Listing Certified Through	2024-12-31

Package

Package Images

NDC 76420-0212-30 (76420021230)

Pricing Information	N/A
NDC Package Code	76420-212-30
Billing NDC	76420021230
Package	1 TUBE in 1 CARTON (76420-212-30) / 3.5 g in 1 TUBE
Marketing Start Date	2022-03-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bccdb8f3-b5f5-4f07-8ddb-8811d5c1b73c Details

SPL UNCLASSIFIED SECTION

Sterile

Rx only

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- O-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-(dimethyl-amino)-β-D- xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione)) is an antibiotic produced from a strain of Streptomyces erythraeus.

It has the following structural formula:

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 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.

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.

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS:

The most frequently reported adverse reactions are minor ocular irritations, redness, and hypersensitivity reactions.

DOSAGE AND ADMINISTRATION:

In the treatment of superficial ocular infections, a ribbon approximately 1 cm in length of Erythromycin Opthalmic 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, 0.5% is available as follows:

3.5 g (1/8 oz) sterile tamper-resistant tube (NDC 76420-212-30 relabeled from NDC 17478-070-35)

STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Avoid excessive heat.

Protect from freezing.

Relabeled by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ERYTHROMYCIN

erythromycin ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:76420-212(NDC:17478-070)
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D)	ERYTHROMYCIN	5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76420-212-30	1 in 1 CARTON	03/08/2022
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA064030	07/18/1996

Labeler - Asclemed USA, Inc. (059888437)

Name	Address	ID/FEI	Business Operations
Establishment
ASCLEMED USA INC. DBA ENOVACHEMASCLEMED USA INC. DBA ENOVACHEM		059888437	relabel(76420-212)

Revised: 3/2022

Document Id: d9ae93e7-f4a8-1df3-e053-2a95a90ae5b1

Set id: bccdb8f3-b5f5-4f07-8ddb-8811d5c1b73c

Version: 1

Effective Time: 20220307