Product Specifications
| Specification | Details |
| Manufacturer / Brand | XGen Pharmaceuticals DJB, Inc. |
| Manufacturer SKU / Item # | 39822110001 |
| NDC Number | 39822-1100-1 (Vial) |
| Active Ingredient | Folic Acid (5 mg/mL as sodium folate) |
| Concentration / Strength | 5 mg per 1 mL |
| Total Content per Vial | 50 mg Folic Acid / 10 mL |
| Volume per Unit | 10 mL |
| Container Type | Glass Multiple-Dose Vial (MDV) |
| Administration Route | Intravenous (IV), Intramuscular (IM), or Subcutaneous (SC) |
| Formulation | Preservative-Containing (1.5% Benzyl Alcohol) / Light-Sensitive |
| Storage Temperature | 20°C to 25°C (68°F to 77°F) (Protect from light) |
| Packaging Configuration | 1 Vial per Box / Package |
| Regulatory Category | Prescription-Only (Rx) |
Key Features & Clinical Applications
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Megaloblastic Anemia Therapy: Indicated for the treatment of megaloblastic anemias resulting from folic acid deficiency, such as tropical or nontropical sprue, nutritional deficiencies, infancy, or pregnancy.
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Parenteral Absorption Advantage: Bypasses intestinal malabsorption pathways in patients with severe gastrointestinal disorders, alcoholism, short bowel syndrome, or sprue where oral supplementation is ineffective.
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Preserved Multi-Dose Vial: Formulated with 1.5% benzyl alcohol to allow multiple sterile withdrawals for individualized clinical dosing protocols.
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Light-Protected Formulation: Packaged in a protective carton to ensure long-term stability and prevent photodegradation of the active sodium folate compound.
⚠️ Diagnostic Precaution: Folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid may produce hematologic remission while neurological damage continues to progress.
⚠️ Neonatal Hazard (Benzyl Alcohol Warning): This product contains benzyl alcohol as a preservative. Benzyl alcohol has been associated with serious adverse events, including the “gasping syndrome,” and death in neonates and low-birth-weight infants. Do not use in neonates or premature infants.
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