Nystatin (Page 2 of 2)

PRINCIPAL DISPLAY PANEL — 5 mL Unit Dose Cup Label

Delivers 5 mL

NDC 0121-0868-05

NYSTATIN ORAL SUSPENSION, USP

500,000 units/5 mL

Alcohol ≤ 1% v/v SHAKE WELL

Package Not Child-Resistant

Rx ONLY

PHARMACEUTICAL ASSOCIATES, INC.,
GREENVILLE, SC 29605

SEE INSERT

A0868051021

NYSTATIN nystatin suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0121-0868 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NYSTATIN (NYSTATIN) NYSTATIN 100000 [USP’U] in 1 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL ANHYDROUS CITRIC ACID D&C YELLOW NO. 10 FD&C RED NO. 40 GLYCERIN METHYLPARABEN POTASSIUM PHOSPHATE, DIBASIC PROPYLENE GLYCOL PROPYLPARABEN WATER SUCROSE MAGNESIUM ALUMINUM SILICATE

Product Characteristics Color yellow (Light — Creamy) Score Shape Size Flavor CHERRY (w/Peppermint) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0121-0868-02 60 mL in 1 BOTTLE, DROPPER None 2 NDC:0121-0868-16 473 mL in 1 BOTTLE None 3 NDC:0121-0868-40 4 TRAY in 1 CASE contains a TRAY 3 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (0121-0868-40) and contains a CUP, UNIT-DOSE (0121-0868-05) 3 NDC:0121-0868-05 5 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (0121-0868-40) 4 NDC:0121-0868-50 5 TRAY in 1 CASE contains a TRAY 4 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (0121-0868-50) and contains a CUP, UNIT-DOSE (0121-0868-05) 4 NDC:0121-0868-05 5 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (0121-0868-50) 5 NDC:0121-0868-00 10 TRAY in 1 CASE contains a TRAY 5 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (0121-0868-00) and contains a CUP, UNIT-DOSE (0121-0868-05) 5 NDC:0121-0868-05 5 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (0121-0868-00)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203621 07/17/2020

Labeler — PAI Holdings, LLC (044940096)

Establishment
Name	Address	ID/FEI	Operations
PAI Holdings, LLC dba Pharmaceutical Associates, Inc.		097630693	analysis (0121-0868), label (0121-0868), manufacture (0121-0868), pack (0121-0868)

Revised: 01/2023 PAI Holdings, LLC