Miconazole Nitrate
Actavis Pharma, Inc.
Human Prescription Drug
NDC 0472-1738Miconazole Nitrate is a human prescription drug labeled by 'Actavis Pharma, Inc.'. National Drug Code (NDC) number for Miconazole Nitrate is 0472-1738. This drug is available in dosage form of Suppository. The names of the active, medicinal ingredients in Miconazole Nitrate drug includes Miconazole Nitrate - 200 mg/1 . The currest status of Miconazole Nitrate drug is Active.
Drug Information:
| Drug NDC: | 0472-1738 |
| 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: | Miconazole Nitrate |
| 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: | Miconazole Nitrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Actavis Pharma, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Suppository |
| 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: | MICONAZOLE NITRATE - 200 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | VAGINAL
|
| 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: | 18 Jan, 1995 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 30 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: | ANDA073508 |
| 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: | Actavis Pharma, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 992765
|
| 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. |
| UNII: | VW4H1CYW1K
|
| 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: | Azole Antifungal [EPC]
Azoles [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 |
|---|
| 0472-1738-03 | 3 SUPPOSITORY in 1 CARTON (0472-1738-03) | 18 Jan, 1995 | 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:
Miconazole nitrate miconazole nitrate miconazole nitrate miconazole hydrogenated palm kernel oil
Indications and Usage:
Indications and usage miconazole nitrate vaginal suppositories usp, 200 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). effectiveness in pregnancy has not been established. as miconazole nitrate is effective only for candidal vulvovaginitis, the diagnosis should be confirmed by koh smear and/or cultures. other pathogens commonly associated with vulvovaginitis ( trichomonas and haemophilus vaginalis [gardnerella] ) should be ruled out by appropriate laboratory methods.
General Precautions:
General discontinue drug if sensitization or irritation is reported during use. the base contained in the suppository formulation may interact with certain latex products, such as that used in vaginal contraceptive diaphragms. concurrent use is not recommended. miconazole nitrate vaginal cream usp, 2% may be considered for use under these conditions.
Dosage and Administration:
Dosage and administration miconazole nitrate vaginal suppositories usp, 200 mg: one suppository (miconazole nitrate, 200 mg) is inserted intravaginally once daily at bedtime for three consecutive days. before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures to rule out other pathogens.
Contraindications:
Contraindications patients known to be hypersensitive to this drug.
Adverse Reactions:
Adverse reactions during clinical studies with miconazole nitrate vaginal suppositories usp, 200 mg, 301 patients were treated. the incidence of vulvovaginal burning, itching or irritation was 2%. complaints of cramping (2%) and headaches (1 . 3%) were also reported. other complaints (hives, skin rash) occurred with less than a 0 . 5% incidence. the therapy-related dropout rate was 0 . 3%. to report suspected adverse events, contact teva pharmaceuticals usa, inc., at 1-888-838-2872 or fda at 1-800-fda-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
Use in Pregnancy:
Pregnancy since imidazoles are absorbed in small amounts from the human vagina, they should not be used in the first trimester of pregnancy unless the physician considers it essential to the welfare of the patient. clinical studies, during which miconazole nitrate vaginal cream and suppositories were used for up to 14 days, were reported to include 541 pregnant patients. follow-up reports available in 471 of these patients reveal no adverse effects or complications attributable to miconazole nitrate therapy in infants born to these women.
Overdosage:
âoverdosage overdosage of miconazole nitrate in humans has not been reported to date. in mice, rats, guinea pigs and dogs, the oral ld 50 values were found to be 578 . 1, greater than 640, 275 . 9 and greater than 160 mg/kg, respectively.
Description:
Description miconazole nitrate vaginal suppositories usp, 200 mg are white to off-white suppositories, each containing the antifungal agent, miconazole nitrate, usp 1-[2,4-dichloro-β-[(2,4- dichlorobenzyl)oxy] phenethyl]-imidazole mononitrate, 200 mg, in a hydrogenated vegetable oil base. the molecular formula is c 18 h 14 cl 4 n 2 oâ¢hno 3 ; the molecular weight is 479.14 and the structural formula may be represented as follows: 009711be-figure-01
Clinical Pharmacology:
Clinical pharmacology miconazole nitrate exhibits fungicidal activity in vitro against species of the genus candida. the pharmacologic mode of action is unknown. following intravaginal administration of miconazole nitrate, small amounts are absorbed. administration of a single dose of miconazole nitrate vaginal suppositories (100 mg) to healthy subjects resulted in total recovery from the urine and feces of 0 . 85% (±0 . 43%) of the administered dose. animal studies indicate that the drug crossed the placenta and doses above those used in humans result in embryo and fetotoxicity (80 mg/kg, orally), although this has not been reported in human subjects (see precautions ). in multi-center clinical trials in 440 women with vulvovaginal candidiasis, the efficacy of treatment with the miconazole nitrate vaginal suppositories usp, 200 mg for 3 days was compared with treatment for 7 days with miconazole nitrate vaginal cream 2%. the clinical cure rates (free of microbiological evidence and
Read more... clinical signs and symptoms of candidiasis at 8 to 10 days and 30 to 35 days post therapy) were numerically lower, although not statistically different, with the 3-day suppository when compared with the 7-day cream.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility long-term animal studies to determine carcinogenic potential have not been performed. fertility (reproduction): oral administration of miconazole nitrate in rats has been reported to produce prolonged gestation. however, this effect was not observed in oral rabbit studies. in addition, signs of fetal and embryo toxicity were reported in rat and rabbit studies, and dystocia was reported in rat studies after oral doses at and above 80 mg per kg. intravaginal administration did not produce these effects in rats.
How Supplied:
How supplied miconazole nitrate vaginal suppositories usp, 200 mg are available as elliptically shaped white to off-white suppositories in packages of three with a vaginal applicator ndc 0472-1738-03. store at controlled room temperature 15° to 30°c (59° to 86°f). manufactured for: teva pharmaceuticals usa, inc. parsippany, nj 07054 rev. a 7/2020
Package Label Principal Display Panel:
Package label.principal display panel ndc 0472-1738-03 miconazole nitrate vaginal suppositories usp, 200 mg for vaginal yeast infections 3-day regimen rx only 3 vaginal suppositories with applicator image