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

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Nystatin Oral Suspension, USP

Description

Clinical Pharmacology

Indications and Usage

label Contraindications

Precautions

Adverse Reactions

Overdosage

Dosage and Administration

How Supplied

Display 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
ALCOHOL (UNII: 3K9958V90M)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CHERRY (UNII: BUC5I9595W)  
SUCROSE (UNII: C151H8M554)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80432-003-33473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06514802/01/2020
Labeler - TriRx Huntsville Pharmaceutical Services, LLC (117090286)
Establishment
NameAddressID/FEIBusiness Operations
TriRx Huntsville Pharmaceutical Services, LLC117090286manufacture(80432-003)

Revised: 1/2023
Document Id: f1f0c6b3-59d7-9770-e053-2a95a90ae26f
Set id: b9d1d7bc-97e4-8fcb-e053-2995a90a7b4c
Version: 2
Effective Time: 20230110
 
TriRx Huntsville Pharmaceutical Services, LLC