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How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

Fentanyl Citrate Injection, USP equivalent to 50 mcg (0.05 mg) fentanyl per mL, is supplied in single-dose ampules and single-dose vials for intramuscular and intravenous administration, and available as follows:

Unit of Sale

Concentration

NDC 0409-9093-32
Clamcell of 10, 2 mL Single-dose Ampules

100 mcg Fentanyl/2 mL
(50 mcg/mL)

NDC 0409-9094-22
Tray containing 25, 2 mL Single-dose Fliptop Vials

100 mcg Fentanyl/2 mL
(50 mcg/mL)

NDC 0409-9093-35
Clamcell of 10, 5 mL Single-dose Ampules

250 mcg Fentanyl/5 mL
(50 mcg/mL)

NDC 0409-9094-25
Tray containing 25, 5 mL Single-dose Fliptop Vials

250 mcg Fentanyl/5 mL
(50 mcg/mL)

NDC 0409-9093-36
Carton containing 5, 10 mL Single-dose Ampules

500 mcg Fentanyl/10 mL
(50 mcg/mL)

NDC 0409-9094-28
Tray containing 25, 10 mL Single-dose Fliptop Vials

500 mcg Fentanyl/10 mL
(50 mcg/mL)

NDC 0409-9093-38
Carton containing 5, 20 mL Single-dose Ampules

1000 mcg Fentanyl/20 mL
(50 mcg/mL)

NDC 0409-9094-31
Tray containing 25, 20 mL Single-dose Fliptop Vials

1000 mcg Fentanyl/20 mL
(50 mcg/mL)

NDC 0409-9094-61
Tray containing 25, 50 mL Single-dose Fliptop Vials

2500 mcg Fentanyl/50 mL
(50 mcg/mL)

Protect from light. Retain in carton until time of use.

Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature.]

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