DOXY Powder for solution for injection Ref.[28060] Active ingredients: Doxycycline

Source: FDA, National Drug Code (US)  Revision Year: 2021 

Product description

Doxycycline for Injection, USP is a sterile, lyophilized powder prepared from a solution of doxycycline hyclate, ascorbic acid and mannitol in Water for Injection. Doxycycline hyclate is a broad spectrum antibiotic derived from oxytetracycline. It is meant for INTRAVENOUS use only after reconstitution. Doxycycline hyclate is a yellowish crystalline powder which is chemically designated 4-(Dimethylamino)-1,4,4a,5,5a,6,11, 12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-de monohydrochloride, compound with ethyl alcohol (2:1), monohydrate.

It has the following structural formula:

(C22H24N2O8 • HCl)2 • C2H6O • H2O

M.W. 1025.89

Doxycycline hyclate is soluble in water and chars at 201°C without melting. The base doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum.

Each 100 mg vial contains: Doxycycline hyclate equivalent to 100 mg doxycycline; ascorbic acid 480 mg; mannitol 300 mg. pH of the reconstituted solution (10 mg/mL) is between 1.8 and 3.3.

How Supplied

Doxycycline for Injection, USP, sterile powder, supplied as follows:

Product Code Unit of Sale Strength Each
NP1311 NDC 63323-130-13
Unit of 10
Doxycycline hyclate equivalent to
100 mg doxycycline per vial
NDC 63323-130-03
10 mL Single Dose Vial

The brand names mentioned in this document are the trademarks of their respective owners.

Novaplus is a registered trademark of Vizient. Inc.

Manufactured by: Fresenius Kabi, Lake Zurich, IL 60047


Drug Countries
DOXY France, Hong Kong, Israel, New Zealand, United States

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