L-Methylfolate Calcium

Name: L-Methylfolate Calcium

Indications and Usage for L-Methylfolate Calcium

L-Methylfolate Calcium 7.5 mg is indicated for the distinct nutritional requirements of patients in need of dietary supplementation as determined by a licensed medical practitioner.

L-Methylfolate Calcium 7.5 mg should be administered under the supervision of a licensed medical practitioner.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Warnings

Caution is recommended in patients with a history of bipolar illness.

Adverse Reactions

Allergic sensitization has been reported following both oral and parental administration of folic acid, and may possibly occur with other forms of folate.

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

VIRTUS
PHARMACEUTICALS

NDC† 76439-206-90

L-Methylfolate
Calcium 7.5 mg
Prescription Dietary Supplement

Rx
90 Tablets

Made in USA

L-Methylfolate Calcium 
levomefolate calcium tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76439-206
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOMEFOLATE CALCIUM (LEVOMEFOLIC ACID) LEVOMEFOLATE CALCIUM 7.5 mg
Inactive Ingredients
Ingredient Name Strength
Croscarmellose sodium  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
calcium phosphate, dibasic, anhydrous  
Silicon Dioxide  
stearic acid  
FD&C BLUE NO. 2  
polyethylene glycols  
polyvinyl alcohol  
talc  
TITANIUM DIOXIDE  
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 14mm
Flavor Imprint Code BP;500
Contains     
Packaging
# Item Code Package Description
1 NDC:76439-206-30 30 TABLET, COATED in 1 BOTTLE
2 NDC:76439-206-90 90 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 03/15/2012
Labeler - Virtus Pharmaceuticals (969483143)
Revised: 08/2012   Virtus Pharmaceuticals
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