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

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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
Document Id: f1f0be1e-39c4-a6d4-e053-2a95a90af0b6
Set id: b95ce95e-ea57-99d5-e053-2a95a90ab217
Version: 2
Effective Time: 20230110
 
TriRx Huntsville Pharmaceutical Services, LLC