Doripenem how supplied: Difference between revisions
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==How Supplied== | ==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. | 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: 50458-401-01 – 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: 50458-401-02 – 500 mg/vial, 10 vials/carton | ||
NDC: 50458-402-02 – 250 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 | ====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].<ref>{{Cite web | last = | first = |title =http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s014lbl.pdf | url =http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s014lbl.pdf | publisher =|date = | accessdate = }}</ref> | 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].<ref>{{Cite web | last = | first = |title =http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s014lbl.pdf | url =http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s014lbl.pdf | publisher =|date = | accessdate = }}</ref> | ||
Latest revision as of 22:15, 5 January 2014
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].[1]
References
- ↑ "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s014lbl.pdf" (PDF). External link in
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Adapted from the FDA Package Insert.