Acyclovir
Mylan Institutional Inc.
Human Prescription Drug
NDC 51079-550Acyclovir is a human prescription drug labeled by 'Mylan Institutional Inc.'. National Drug Code (NDC) number for Acyclovir is 51079-550. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Acyclovir drug includes Acyclovir - 50 mg/g . The currest status of Acyclovir drug is Active.
Drug Information:
| Drug NDC: | 51079-550 |
| 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: | Acyclovir |
| 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: | Acyclovir |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Mylan Institutional 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: | ACYCLOVIR - 50 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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: | 27 Nov, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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: | ANDA202459 |
| 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: | Mylan Institutional Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 197312
|
| 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. |
| NUI: | N0000020060
N0000180187
N0000180188
N0000175468
N0000175459
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | X4HES1O11F
|
| 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 MOA: | DNA Polymerase Inhibitors [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [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: | DNA Polymerase Inhibitors [MoA]
Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
Nucleoside Analog [EXT]
|
| 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 |
|---|
| 51079-550-68 | 2 TUBE in 1 CARTON (51079-550-68) / 5 g in 1 TUBE (51079-550-67) | 27 Nov, 2013 | 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:
Acyclovir acyclovir polyethylene glycol, unspecified acyclovir acyclovir opaque white to off-white
Drug Interactions:
Drug interactions clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with acyclovir ointment 5%.
Indications and Usage:
Indications and usage acyclovir ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous herpes simplex virus infections in immunocompromised patients.
Warnings:
Warnings acyclovir ointment 5% is intended for cutaneous use only and should not be used in the eye.
General Precautions:
General the recommended dosage, frequency of applications and length of treatment should not be exceeded (see dosage and administration ). there are no data to support the use of acyclovir ointment 5% to prevent transmission of infection to other persons or prevent recurrent infections when applied in the absence of signs and symptoms. acyclovir ointment 5% should not be used for the prevention of recurrent hsv infections. although clinically significant viral resistance associated with the use of acyclovir ointment 5% has not been observed, this possibility exists.
Dosage and Administration:
Dosage and administration apply sufficient quantity to adequately cover all lesions every 3 hours, 6 times per day for 7 days. the dose size per application will vary depending upon the total lesion area but should approximate a one-half inch ribbon of ointment per 4 square inches of surface area. a finger cot or rubber glove should be used when applying acyclovir ointment to prevent autoinoculation of other body sites and transmission of infection to other persons. therapy should be initiated as early as possible following onset of signs and symptoms.
Contraindications:
Contraindications acyclovir ointment 5% is contraindicated in patients who develop hypersensitivity to the components of the formulation.
Adverse Reactions:
Adverse reactions in the controlled clinical trials, mild pain (including transient burning and stinging) was reported by about 30% of patients in both the active and placebo arms; treatment was discontinued in 2 of these patients. local pruritus occurred in 4% of these patients. in all studies, there was no significant difference between the drug and placebo group in the rate or type of reported adverse reactions nor were there any differences in abnormal clinical laboratory findings. observed during clinical practice based on clinical practice experience in patients treated with acyclovir ointment in the u.s., spontaneously reported adverse events are uncommon. data are insufficient to support an estimate of their incidence or to establish causation. these events may also occur as part of the underlying disease process. voluntary reports of adverse events that have been received since market introduction include: general: edema and/or pain at the application site. skin: pruritus, ras
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Drug Interactions:
Drug interactions clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with acyclovir ointment 5%.
Use in Pregnancy:
Pregnancy teratogenic effects acyclovir was not teratogenic in the mouse, rabbit, or rat at exposures greatly in excess of human exposure. there are no adequate and well-controlled studies of systemic acyclovir in pregnant women. a prospective epidemiologic registry of acyclovir use during pregnancy was established in 1984 and completed in april 1999. there were 749 pregnancies followed in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in 756 outcomes. the occurrence rate of birth defects approximates that found in the general population. however, the small size of the registry is insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses. systemic acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric Use:
Pediatric use safety and effectiveness in pediatric patients have not been established.
Geriatric Use:
Geriatric use clinical studies of acyclovir ointment did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. systemic absorption of acyclovir after topical administration is minimal (see clinical pharmacology ).
Overdosage:
Overdosage overdosage by topical application of acyclovir ointment 5% is unlikely because of limited transcutaneous absorption (see clinical pharmacology ).
Description:
Description acyclovir ointment, usp is a synthetic nucleoside analogue active against herpes viruses. acyclovir ointment 5% is a formulation for topical administration. each gram of acyclovir ointment 5% contains 50 mg of acyclovir in a polyethylene glycol (peg) base. acyclovir, usp is a white to off-white, crystalline powder with the molecular formula c 8 h 11 n 5 o 3 and a molecular weight of 225. the maximum solubility in water at 37°c is 2.5 mg/ml. the pkaâs of acyclovir are 2.27 and 9.25. the chemical name of acyclovir is 9-[(2-hydroxyethoxy)methyl]guanine; it has the following structural formula: acyclovir structural formula
Clinical Pharmacology:
Clinical pharmacology two clinical pharmacology studies were performed with acyclovir ointment 5% in immunocompromised adults at risk of developing mucocutaneous herpes simplex virus infections or with localized varicella-zoster infections. these studies were designed to evaluate the dermal tolerance, systemic toxicity, and percutaneous absorption of acyclovir. in 1 of these studies, which included 16 inpatients, the complete ointment or its vehicle were randomly administered in a dose of 1-cm strips (25 mg acyclovir) 4 times a day for 7 days to an intact skin surface area of 4.5 square inches. no local intolerance, systemic toxicity, or contact dermatitis were observed. in addition, no drug was detected in blood and urine by radioimmunoassay (sensitivity, 0.01 mcg/ml). the other study included 11 patients with localized varicella-zoster infections. in this uncontrolled study, acyclovir was detected in the blood of 9 patients and in the urine of all patients tested. acyclovir levels in
Read more... plasma ranged from < 0.01 to 0.28 mcg/ml in 8 patients with normal renal function, and from < 0.01 to 0.78 mcg/ml in 1 patient with impaired renal function. acyclovir excreted in the urine ranged from < 0.02% to 9.4% of the daily dose. therefore, systemic absorption of acyclovir after topical application is minimal.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility systemic exposure following topical administration of acyclovir is minimal. dermal carcinogenicity studies were not conducted. results from the studies of carcinogenesis, mutagenesis and fertility are not included in the full prescribing information for acyclovir ointment 5% due to the minimal exposures of acyclovir that result from dermal application. information on these studies is available in the full prescribing information for acyclovir capsules, tablets and suspension and acyclovir for injection.
How Supplied:
How supplied: each gram of acyclovir ointment usp, 5% contains acyclovir usp, 50 mg in a polyethylene glycol base. acyclovir ointment usp, 5% is an opaque white to off-white ointment available as follows: 51079-550-68 carton of two 5 g tubes store at 20° to 25°c (68° to 77°f). [see usp controlled room temperature.] store in a dry place. manufactured for: mylan institutional inc. rockford, il 61103 u.s.a. manufactured by: mylan institutional inc. sugar land, tx 77478 u.s.a. revised: 7/2018 acyco:5g:r4 1343.4 [pharma code: 3434]
Package Label Principal Display Panel:
Principal display panel â 5% ndc 51079-550-68 rx only acyclovir 5% ointment, usp 2 pack (5 g each) each gram contains acyclovir, usp 50 mg in a polyethylene glycol base. usual dosage: apply 6 times a day (every 3 hours) for 7 days. see prescribing information for dosage information. store at 20° to 25°c (68° to 77°f). [see usp controlled room temperature.] store in a dry place. manufactured for: mylan institutional inc. rockford, il 61103 u.s.a. manufactured by: mylan institutional inc. sugar land, tx 77478 u.s.a. mylan.com mi550:68:0c:r4 1234.4 acyclovir ointment, usp 5% carton label