NDC Code(s) : 11704-270-01
Packager : Meridian Medical Technologies, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cyanokit hydroxocobalamin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11704-270
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
hydroxocobalamin (UNII: Q40X8H422O)
(hydroxocobalamin - UNII:Q40X8H422O) 		hydroxocobalamin 2.5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
hydrochloric acid(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:11704-270-012 in 1 CARTON
1100 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022041 08/31/2009

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 5 g BOTTLE LABEL

Cyanokit ® 5 g

Hydroxocobalamin for Injection

(2.5 g per vial)

For Intravenous Use

To be reconstituted with 100 mL

per vial of 0.9% Sodium Chloride Injection

Diluent Not Included

Rx Only

Manufactured by:

Merck Santé s.a.s.,

Semoy, France

Distributed by

Meridian Medical TechnologiesTM, Inc.

Columbia, MD 21046

A wholly-owned subsidiary of King Pharmaceuticals®, Inc.

1-800-776-3637

MERIDIAN

MEDICAL TECHNOLOGIES™

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 5 g BOTTLE LABEL

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 5 g INNER CARTON

Cyanokit ® 5 g

Hydroxocobalamin for Injection

(2.5 g per vial)

For Intravenous Use

To be reconstituted with 100 mL

per vial of 0.9% Sodium Chloride Injection

Diluent Not Included

Rx Only

Manufactured by:

Merck Santé s.a.s.,

Semoy, France

Distributed by

Meridian Medical TechnologiesTM, Inc.

Columbia, MD 21046

A wholly-owned subsidiary of King Pharmaceuticals®, Inc.

1-800-776-3637

MERIDIAN

MEDICAL TECHNOLOGIES™

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 5 g INNER CARTON

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 5 g OUTER CARTON

Cyanokit ® 5 g

Hydroxocobalamin for Injection

(2.5 g per vial)

For Intravenous Use

To be reconstituted with 100 mL

per vial of 0.9% Sodium Chloride Injection

Diluent Not Included

Rx Only

Manufactured by:

Merck Santé s.a.s.,

Semoy, France

Distributed by

Meridian Medical TechnologiesTM, Inc.

Columbia, MD 21046

A wholly-owned subsidiary of King Pharmaceuticals®, Inc.

1-800-776-3637

MERIDIAN

MEDICAL TECHNOLOGIES™

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 5 g OUTER CARTON

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 5 g PATIENT INSTRUCTION CARD SIDE A

Cyanokit ® 5 g

Hydroxocobalamin for Injection

(2.5 g per vial)

For Intravenous Use

To be reconstituted with 100 mL

per vial of 0.9% Sodium Chloride Injection

Diluent Not Included

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 5 g PATIENT INSTRUCTION CARD SIDE A

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 5 g PATIENT INSTRUCTION CARD SIDE B

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 5 g PATIENT INSTRUCTION CARD SIDE A