Request Item

IMMUNE GLOBULIN GAMUNEX INJ HUMAN 10%

Generic: Immune Globulin (Human)

NDC:13533-0800-20

Manufacturer:GRIFOLS USA, LLC

Strength:10 g/100mL

Dosage Form:INJECTION

Route:INTRAVENOUS, SUBCUTANEOUS

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Drug Information

Identification

Generic Name

Immune Globulin (Human)

Brand Name

Gamunex-C

Labeler / Distributor

GRIFOLS USA, LLC

Product Type

PLASMA DERIVATIVE

Administration

Dosage Form

INJECTION

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

FDA Application Number

BLA125046

Active Ingredients

Ingredient	Strength
HUMAN IMMUNOGLOBULIN G	10 g/100mL

Pharmacological Class

Antigen Neutralization [MoA]Human Immunoglobulin GImmunoglobulins [CS]Passively Acquired Immunity [PE]

Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.

Wholesale compliance resources

DSCSA T2 documents DSCSA compliance resource hub

Drug Resources

Immune globulin (human) Drug Page NDC 13533-0800-20 Lookup

Clinical Drug Information

Indications & Usage

Use for relief of occasional sleeplessness caused by stress and repetitive thoughts

Warnings

Warnings When using this product keep away from eyes Stop use and ask a doctor if sleeplessness persists for more than two weeks: insomnia can be a symptom of serious underlying medical illness If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions adults: apply 2 sprays onto the tongue. Additional sprays may be taken during the night as needed. children under 12: ask a doctor

Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.