Nystatin by TriRx Huntsville Pharmaceutical Services, LLC

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 
nystatin oral suspension suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 80432-003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E)	NYSTATIN	100000 [USP'U]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80432-003-08	60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	09/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA065148	09/01/2019	09/30/2023

Labeler - TriRx Huntsville Pharmaceutical Services, LLC (117090286)

Establishment
Name	Address	ID/FEI	Business Operations
TriRx Huntsville Pharmaceutical Services, LLC		117090286	manufacture(80432-003)

Revised: 8/2024

Document Id: 1f7d60cd-389e-f973-e063-6294a90a7376

34391-3

Set id: b95ce95e-ea57-99d5-e053-2a95a90ab217

Version: 4

Effective Time: 20240812

 

TriRx