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NDC 63629-8350-01 nystatin 500000 [USP'U]/1 Details

nystatin 500000 [USP'U]/1

nystatin is a ORAL TABLET, COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is NYSTATIN.

MedlinePlus Drug Summary

Nystatin is used to treat fungal infections of the inside of the mouth and lining of the stomach and intestines. Nystatin is in a class of antifungal medications called polyenes. It works by stopping the growth of fungi that cause infection.

Related Packages: 63629-8350-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Nystatin

Product Information

NDC	63629-8350
Product ID	63629-8350_e7ae5c6e-7675-492b-a7ad-7137e6839a9e
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	nystatin
Proprietary Name Suffix	n/a
Non-Proprietary Name	nystatin
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, COATED
Route	ORAL
Active Ingredient Strength	500000
Active Ingredient Units	[USP'U]/1
Substance Name	NYSTATIN
Labeler Name	Bryant Ranch Prepack
Pharmaceutical Class	Polyene Antifungal [EPC], Polyenes [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA062474
Listing Certified Through	2023-12-31

Package

Package Images

NDC 63629-8350-01 (63629835001)

Pricing Information	N/A
NDC Package Code	63629-8350-1
Billing NDC	63629835001
Package	28 TABLET, COATED in 1 BOTTLE (63629-8350-1)
Marketing Start Date	2022-04-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a5711dbe-f71c-435c-91f2-38c357532d18 Details

DESCRIPTION

Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei . Its structural formula:

C47H75NO17 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

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.

INDICATIONS AND USAGE

Nystatin Tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.

CONTRAINDICATIONS

Nystatin tablets are contraindicated in patients with a history of hypersensitivity to any of their components.

PRECAUTIONS

General

This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.

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.

Nursing Mothers

It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman.

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.

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).

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.

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

PRINCIPAL DISPLAY PANEL

Nystatin(oral) 500,000 Units Tablet

INGREDIENTS AND APPEARANCE

NYSTATIN

nystatin tablet, coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:63629-8350(NDC:23155-051)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E)	NYSTATIN	500000 [USP'U]

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
SUCROSE (UNII: C151H8M554)
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Product Characteristics
Color	BROWN	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	HP;51
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63629-8350-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/05/2020
2	NDC:63629-8350-1	28 in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2022
3	NDC:63629-8350-2	56 in 1 BOTTLE; Type 0: Not a Combination Product	09/02/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA062474	10/31/2011

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(63629-8350) , RELABEL(63629-8350)

Revised: 4/2022

Document Id: e7ae5c6e-7675-492b-a7ad-7137e6839a9e

Set id: a5711dbe-f71c-435c-91f2-38c357532d18

Version: 6

Effective Time: 20220429