Erythromycin
Henry Schein Inc.
Human Prescription Drug
NDC 0404-7191Erythromycin is a human prescription drug labeled by 'Henry Schein Inc.'. National Drug Code (NDC) number for Erythromycin is 0404-7191. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Erythromycin drug includes Erythromycin - 5 mg/g . The currest status of Erythromycin drug is Active.
Drug Information:
| Drug NDC: | 0404-7191 |
| 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: | Erythromycin |
| 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: | Erythromycin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Henry Schein Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Ointment |
| 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: | ERYTHROMYCIN - 5 mg/g
|
| 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: | 13 May, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 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: | ANDA064030 |
| 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: | Henry Schein Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 310149
|
| 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. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0304047191012
|
| UPC stands for Universal Product Code. |
| NUI: | N0000009982
N0000175877
N0000175935
M0028311
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 63937KV33D
|
| 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 EPC: | Macrolide [EPC]
Macrolide Antimicrobial [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Decreased Sebaceous Gland Activity [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class CS: | Macrolides [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Decreased Sebaceous Gland Activity [PE]
Macrolide Antimicrobial [EPC]
Macrolide [EPC]
Macrolides [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 |
|---|
| 0404-7191-01 | 1 TUBE in 1 CARTON (0404-7191-01) / 3.5 g in 1 TUBE | 13 May, 2015 | 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:
Erythromycin erythromycin erythromycin erythromycin petrolatum mineral oil
Indications and Usage:
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.
General 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.
Dosage and Administration:
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.
Contraindications:
Contraindications: this drug is contraindicated in patients with a history of hypersensitivity to erythromycin.
Adverse Reactions:
Adverse reactions: the most frequently reported adverse reactions are minor ocular irritations, redness, and hypersensitivity reactions.
Use in Pregnancy:
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.
Pediatric Use:
Pediatric use - see indications and usage and dosage and administration .
Geriatric Use:
Geriatric use: no overall differences in safety or effectiveness have been observed between elderly and younger patients.
Description:
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. structural formula
Clinical Pharmacology:
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
Carcinogenesis and Mutagenesis and Impairment of Fertility:
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.
How Supplied:
How supplied: sterile erythromycin ophthalmic ointment usp, 0.5% is available as follows: 3.5 g (1/8 oz) sterile tamper-resistant tube (ndc 0404-7191-01) storage: store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. avoid excessive heat. protect from freezing. distributed by (in us only): henry schein inc. 135 duryea road melville, ny 11747 usa bert00n rev. 08/14
Information for Patients:
Information for patients: avoid contaminating the applicator tip with material from the eye, fingers, or other source.
Package Label Principal Display Panel:
Principal display panel text for container label: henry schein logo ndc 0404-7191-01 112-7191 erythromycin ophthalmic ointment usp, 0.5% sterile rx only net wt. 3.5 g (1/8 oz.) principal display panel text for container label
Principal display panel text for carton label: henry schein logo ndc 0404-7191-01 112-7191 erythromycin ophthalmic ointment usp, 0.5% rx only sterile net wt. 3.5 g (1/8 oz.) principal display panel text for carton label