The following Structured Product Label (SPL) was submitted to the FDA by Milla Pharmaceuticals Inc. for the product Sodium Acetate (NDC 71357-008). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
SODIUM ACETATE
Injection, USP
Pharmacy Bulk Package. Not for Direct Infusion |
FOR ADDITIVE USE ONLY AFTER DILUTION
IN IV FLUIDS.
Glass Fliptop Vial
Rx only
Manufactured by:
S.M. Farmaceutici SRL
Tito – 85050, Italy
Distributed by:
Milla Pharmaceuticals Inc., an A.forall Company
White Bear Lake, MN 55110
Image Description (Milla Pharmaceuticals Company Logo)
Revised: June 2024
Sodium Acetate Injection, USP 100 mEq/50mL - 71357-007-01 - Vial Label
Image Description (Sodium Acetate 100meq Vial Label)
Sodium Acetate Injection, USP 100 mEq/50mL - 71357-007-10 - Carton Label
Image Description (Sodium Acetate 100meq Carton Label)
Sodium Acetate Injection, USP 200 mEq/100mL - 71357-008-01 - Vial Label
Image Description (Sodium Acetate 200meq Vial Label)
Sodium Acetate Injection, USP 200 mEq/100mL - 71357-008-10 - Carton Label
Image Description (Sodium Acetate 200meq Carton Label)
Sodium Acetate Injection, USP 400 mEq/100mL - 71357-009-01 - Vial Label
Image Description (Sodium Acetate 400meq Vial Label)
Sodium Acetate Injection, USP 400 mEq/100mL - 71357-009-10 - Carton Label
Image Description (Sodium Acetate 400meq Carton Label)
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