Nystatin
Bryant Ranch Prepack
Human Prescription Drug
NDC 63629-8350Nystatin is a human prescription drug labeled by 'Bryant Ranch Prepack'. National Drug Code (NDC) number for Nystatin is 63629-8350. This drug is available in dosage form of Tablet, Coated. The names of the active, medicinal ingredients in Nystatin drug includes Nystatin - 500000 [USP'U]/1 . The currest status of Nystatin drug is Active.
Drug Information:
| Drug NDC: | 63629-8350 |
| 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: | Nystatin |
| 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: | Nystatin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bryant Ranch Prepack |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Coated |
| 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: | NYSTATIN - 500000 [USP'U]/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| 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: | 31 Oct, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 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: | ANDA062474 |
| 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: | Bryant Ranch Prepack
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 312059
|
| 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: | N0000175498
M0017172
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | BDF1O1C72E
|
| 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: | Polyene Antifungal [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 CS: | Polyenes [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: | Polyene Antifungal [EPC]
Polyenes [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 |
|---|
| 63629-8350-1 | 28 TABLET, COATED in 1 BOTTLE (63629-8350-1) | 29 Apr, 2022 | N/A | No |
| 63629-8350-2 | 56 TABLET, COATED in 1 BOTTLE (63629-8350-2) | 02 Sep, 2020 | N/A | No |
| 63629-8350-3 | 30 TABLET, COATED in 1 BOTTLE (63629-8350-3) | 05 Oct, 2020 | 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:
Nystatin nystatin nystatin nystatin starch, corn sucrose hydroxypropyl cellulose (90000 wamw) isopropyl alcohol anhydrous dibasic calcium phosphate microcrystalline cellulose talc magnesium stearate hypromellose 2910 (6 mpa.s) hypromellose 2910 (3 mpa.s) polyethylene glycol 400 polyethylene glycol 8000 titanium dioxide fd&c yellow no. 6 fd&c red no. 40 fd&c blue no. 2 polysorbate 80 hp;51 image
Indications and Usage:
Indications and usage nystatin tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.
Dosage and Administration:
Dosage and administration the usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units nystatin) three times daily. treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.
Contraindications:
Contraindications nystatin tablets are contraindicated in patients with a history of hypersensitivity to any of their components.
Adverse Reactions:
Adverse reactions nystatin is well tolerated even with prolonged therapy. oral irritation and sensitization have been reported. (see precautions: general . ) gastrointestinal diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances. dermatologic rash, including urticaria has been reported rarely. stevens-johnson syndrome has been reported very rarely. other tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been rarely reported. to report suspected adverse reactions, contact avet pharmaceuticals inc. at 1-866-901-drug (3784) or fda at 1-800-fda-1088 or www.fda.gov/medwatch .
Use in Pregnancy:
Pregnancy teratogenic effects category c animal reproduction studies have not been conducted with nystatin. it is also not known whether nystatin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. nystatin should be given to a pregnant woman only if clearly needed.
Overdosage:
Overdosage oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset. there have been no reports of serious toxic effects of superinfections (see clinical pharmacology, pharmacokinetics ).
Description:
Description nystatin is an antimycotic polyene antibiotic obtained from streptomyces noursei . its structural formula: c 47 h 75 no 17 m.w. 926.13 nystatin tablets are for oral administration and contain 500,000 units of nystatin per tablet. nystatin tablets contain the inactive ingredients: corn starch, confectioner sugar, dibasic calcium phosphate, fd&c yellow #6, fd&c red #40, fd&c blue # 2, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, polysorbate 80, talc and titanium dioxide.
Clinical Pharmacology:
Clinical pharmacology pharmacokinetics gastrointestinal absorption of nystatin is insignificant. most orally administered nystatin is passed unchanged in the stool. in patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur. microbiology nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. candida albicans demonstrates no significant resistance to nystatin in vitro on repeated subculture in increasing levels of nystatin; other candida species become quite resistant. generally, resistance does not develop in vivo . nystatin acts by binding to sterols in the cell membrane of susceptible candida species with a resultant change in membrane permeability allowing leakage of intracellular components. nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.
Pharmacokinetics:
Pharmacokinetics gastrointestinal absorption of nystatin is insignificant. most orally administered nystatin is passed unchanged in the stool. in patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur.
How Supplied:
How supplied ndc: 63629-8350-3: 30 tablets in a bottle ndc: 63629-8350-1: 28 tablets in a bottle ndc: 63629-8350-2: 56 tablets in a bottle
Package Label Principal Display Panel:
Nystatin(oral) 500,000 units tablet label