Fentanyl Citrate (Page 8 of 8)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Fentanyl Citrate 100 mcg per 2 mL Vial Label

NDC 63323-806-12

Fentanyl

Citrate Injection, USP CII

100 mcg per 2 mL

(50 mcg per mL) (0.05 mg per mL)

FOR INTRAVENOUS OR INTRAMUSCULAR USE

Preservative-free

2 mL Single-Dose Vial Rx only

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Fentanyl Citrate 100 mcg per 2 mL Carton

NDC 63323-806-02

Fentanyl

Citrate Injection, USP CII

100 mcg per 2 mL

(50 mcg per mL) (0.05 mg per mL)*

FOR INTRAVENOUS OR INTRAMUSCULAR USE

Preservative-free

25 x 2 mL

Single-Dose Vials Rx only

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Fentanyl Citrate 250 mcg per 5 mL Vial Label

NDC 63323-806-13

Fentanyl

Citrate Injection, USP CII

250 mcg per 5 mL

(50 mcg per mL)

(0.05 mg per mL)*

FOR INTRAVENOUS OR INTRAMUSCULAR USE

Preservative-free

5 mL

Single-Dose Vial Rx only

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Fentanyl Citrate 250 mcg per 5 mL Carton

NDC 63323-806-05

Fentanyl

Citrate Injection, USP CII

250 mcg per 5 mL

(50 mcg per mL) (0.05 mg per mL)*

FOR INTRAVENOUS OR INTRAMUSCULAR USE

Preservative-free

25 x 5 mL

Single-Dose Vials Rx only

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Fentanyl Citrate 1,000 mcg per 20 mL Vial Label

NDC 63323-806-14

Fentanyl

Citrate Injection, USP CII

1,000 mcg per 20 mL

(50 mcg per mL) (0.05 mg per mL)*

FOR SLOW INTRAVENOUS USE

BY HOSPITAL PERSONNEL SPECIFICALLY

TRAINED IN THE USE OF NARCOTIC ANALGESICS

Preservative-free

20 mL

Single-Dose Vial Rx only

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Fentanyl Citrate 1,000 mcg per 20 mL Carton

NDC 63323-806-20

Fentanyl

Citrate Injection, USP CII

1,000 mcg per 20 mL

(50 mcg per mL) (0.05 mg per mL)*

FOR SLOW INTRAVENOUS USE

BY HOSPITAL PERSONNEL

SPECIFICALLY TRAINED IN THE

USE OF NARCOTIC ANALGESICS

Preservative-free

25 x 20 mL

Single-Dose Vials Rx only

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Fentanyl Citrate 2,500 mcg per 50 mL Vial Label

NDC 63323-806-50

Fentanyl

Citrate Injection, USP CII

2,500 mcg per 50 mL

(50 mcg per mL) (0.05 mg per mL)*

FOR SLOW INTRAVENOUS USE

BY HOSPITAL PERSONNEL SPECIFICALLY

TRAINED IN THE USE OF NARCOTIC

ANALGESICS

Preservative-free

50 mL

Single-Dose Vial Rx only

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Fentanyl Citrate 2,500 mcg per 50 mL Carton

NDC 63323-806-50

Fentanyl

Citrate Injection, USP CII

2,500 mcg per 50 mL

(50 mcg per mL) (0.05 mg per mL)*

FOR SLOW INTRAVENOUS USE

BY HOSPITAL PERSONNEL

SPECIFICALLY TRAINED IN THE

USE OF NARCOTIC ANALGESICS

Preservative-free

50 mL

Single-Dose Vial Rx only

FENTANYL CITRATE fentanyl citrate injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-806 Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fentanyl Citrate (Fentanyl) Fentanyl 0.05 mg in 1 mL

Inactive Ingredients Ingredient Name Strength Hydrochloric Acid Sodium Hydroxide Water

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63323-806-01 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (63323-806-11) 1 NDC:63323-806-11 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (63323-806-01) 2 NDC:63323-806-02 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (63323-806-12) 2 NDC:63323-806-12 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (63323-806-02) 3 NDC:63323-806-05 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (63323-806-13) 3 NDC:63323-806-13 5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (63323-806-05) 4 NDC:63323-806-20 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (63323-806-14) 4 NDC:63323-806-14 20 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (63323-806-20) 5 NDC:63323-806-50 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE 5 50 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (63323-806-50)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210762 05/03/2019

Labeler — Fresenius Kabi USA, LLC (608775388)

Establishment
Name	Address	ID/FEI	Operations
Fresenius Kabi USA, LLC		840771732	manufacture (63323-806), analysis (63323-806)

Revised: 10/2021 Fresenius Kabi USA, LLC