Doripenem how supplied

Doripenem
DORIBAX® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

How Supplied

DORIBAX® is supplied as single use type 1 clear glass vials containing 250 mg or 500 mg (on an anhydrous basis) of sterile doripenem powder. Vials are packaged individually and in cartons containing 10 vials.

• NDC: 50458-401-01 – 500 mg/vial, single vial

• NDC: 50458-401-02 – 500 mg/vial, 10 vials/carton

• NDC: 50458-402-01 – 250 mg/vial, single vial

• NDC: 50458-402-02 – 250 mg/vial, 10 vials/carton

Storage of DORIBAX® vials

DORIBAX® should be stored at 25°C (77°F); excursions permitted to 15°–30°C (59° to 86°F) [refer to USP controlled room temperature].

References

Adapted from the FDA Package Insert.