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 Vial Label
(click image for full-size original)

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 100 mcg per 2 mL Carton
(click image for full-size original)

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 Vial Label
(click image for full-size original)

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 250 mcg per 5 mL Carton
(click image for full-size original)

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 Vial Label
(click image for full-size original)

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 1,000 mcg per 20 mL Carton
(click image for full-size original)

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 Vial Label
(click image for full-size original)

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

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Fentanyl Citrate 2,500 mcg per 50 mL Carton
(click image for full-size original)
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

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