Acyclovir
Amneal Pharmaceuticals Llc
Human Prescription Drug
NDC 65162-835Acyclovir is a human prescription drug labeled by 'Amneal Pharmaceuticals Llc'. National Drug Code (NDC) number for Acyclovir is 65162-835. 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: | 65162-835 |
| 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: | Amneal Pharmaceuticals Llc |
| 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: | 03 Jan, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 11 Jan, 2026 |
| 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: | ANDA204605 |
| 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: | Amneal Pharmaceuticals LLC
|
| 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. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0365162835946
0365162835960
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 65162-835-94 | 1 TUBE in 1 CARTON (65162-835-94) / 15 g in 1 TUBE | 03 Jan, 2014 | N/A | No |
| 65162-835-96 | 1 TUBE in 1 CARTON (65162-835-96) / 30 g in 1 TUBE | 03 Jan, 2014 | 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 acyclovir acyclovir polyethylene glycol, unspecified
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.
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 5% 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 5% in the us, 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, r
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Overdosage:
Overdosage overdosage by topical application of acyclovir ointment 5% is unlikely because of limited transcutaneous absorption (see clinical pharmacology ).
Description:
Description acyclovir, usp, is a synthetic nucleoside analogue active against herpes viruses. acyclovir ointment, usp 5% is a formulation for topical administration. each gram of acyclovir ointment, usp 5% contains 50 mg of acyclovir, usp in a polyethylene glycol (peg) base. acyclovir, usp is a 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, usp are 2.27 and 9.25. the chemical name of acyclovir, usp is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 h -purin-6-one; it has the following structural formula: virology mechanism of antiviral action: acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (hsv-1), 2 (hsv-2), and varicella-zoster virus (vzv). the inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (tk) encoded by hsv and vzv. this viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. the monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. in vitro , acyclovir triphosphate stops replication of herpes viral dna. this is accomplished in 3 ways: 1) competitive inhibition of viral dna polymerase, 2) incorporation into and termination of the growing viral dna chain, and 3) inactivation of the viral dna polymerase. the greater antiviral activity of acyclovir against hsv compared to vzv is due to its more efficient phosphorylation by the viral tk. antiviral activities: the quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (ic 50 ), vary greatly depending upon a number of factors. using plaque-reduction assays, the ic 50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/ml for hsv-1 and from 0.01 to 9.9 mcg/ml for hsv-2. the ic 50 for acyclovir against most laboratory strains and clinical isolates of vzv ranges from 0.12 to 10.8 mcg/ml. acyclovir also demonstrates activity against the oka vaccine strain of vzv with a mean ic 50 of 1.35 mcg/ml. drug resistance: resistance of hsv and vzv to acyclovir can result from qualitative and quantitative changes in the viral tk and/or dna polymerase. clinical isolates of hsv and vzv with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced hiv infection. while most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be tk-deficient mutants, other mutants involving the viral tk gene (tk partial and tk altered) and dna polymerase have been isolated. tk-negative mutants may cause severe disease in infants and immunocompromised adults. the possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy. eae4daa9-figure-01
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. clinical trials in clinical trials of initial genital herpes infections, acyclovir ointment 5% has shown a decrease in healing time and, in some cases, a decrease in duration of viral shedding and duration of pain. in studies in immunocompromised patients mainly with herpes labialis, there was a decrease in duration of viral shedding and a slight decrease in duration of pain. in studies of recurrent genital herpes and of herpes labialis in nonimmunocompromised patients, there was no evidence of clinical benefit; there was some decrease in duration of viral shedding.
How Supplied:
How supplied acyclovir ointment, usp 5% is supplied as a white color ointment. each gram of acyclovir ointment, usp 5% contains 50 mg acyclovir, usp in a polyethylene glycol base. it is supplied as follows: 15-g tubes (ndc 65162-835-94) 30-g tubes (ndc 65162-835-96) store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. store in a dry place. distributed by: amneal pharmaceuticals bridgewater, nj 08807 rev. 02-2016-01
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