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

5 mL unit dose cup label
(click image for full-size original)
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

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