Nystatin Oral Suspension, USP

Nystatin by

Drug Labeling and Warnings

Nystatin by is a Prescription medication manufactured, distributed, or labeled by TriRx Huntsville Pharmaceutical Services, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NYSTATIN- nystatin oral suspension suspension 
TriRx Huntsville Pharmaceutical Services, LLC

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Nystatin Oral Suspension, USP

Description

Clinical Pharmacology

Indications and Usage

Contraindications

Precautions

Adverse Reactions

Overdosage

Dosage and Administration

How Supplied

Display image

Carton Label

NYSTATIN 
nystatin oral suspension suspension
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 80432-003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E) NYSTATIN100000 [USP'U]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CHERRY (UNII: BUC5I9595W)  
SUCROSE (UNII: C151H8M554)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80432-003-0860 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product09/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06514809/01/2019
Labeler - TriRx Huntsville Pharmaceutical Services, LLC (117090286)
Establishment
NameAddressID/FEIBusiness Operations
TriRx Huntsville Pharmaceutical Services, LLC117090286manufacture(80432-003)

Revised: 1/2023
 
TriRx

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