NORMOSOL-R- sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride injection, solution

Normosol-R by

Drug Labeling and Warnings

Normosol-R by is a Prescription medication manufactured, distributed, or labeled by ICU Medical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • PRINCIPAL DISPLAY PANEL - 500 mL Bag Label

    500 mL
    NDC: 0990-7670-03

    NORMOSOL®-R pH 7.4
    MULTIPLE ELECTROLYTES INJECTION TYPE 1, USP

    EACH 100 mL CONTAINS SODIUM CHLORIDE 526 mg; SODIUM ACETATE,
    ANHYD. 222 mg; SODIUM GLUCONATE 502 mg; POTASSIUM CHLORIDE
    37 mg; MAGNESIUM CHLORIDE, HEXAHYDRATE 30 mg IN WATER FOR INJECTION. MAY
    CONTAIN HYDROCHLORIC ACID AND/OR SODIUM HYDROXIDE FOR pH ADJUSTMENT.
    ELECTROLYTES PER 1000 mL (NOT INCLUDING pH ADJUSTMENT): SODIUM 140 mEq;
    POTASSIUM 5 mEq; MAGNESIUM 3 mEq; CHLORIDE 98 mEq; ACETATE 27 mEq; GLUCONATE
    23 mEq.
    295 mOsmol/LITER (CALC).
    pH 6.5 TO 7.6

    ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN
    INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE.

    SINGLE-DOSE CONTAINER. FOR INTRAVENOUS OR SUBCUTANEOUS USE.USUAL DOSAGE: SEE
    INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS
    UNDAMAGED. MUST NOT BE USED
    IN SERIES CONNECTIONS.

    Rx ONLY

    3
    v
    CONTAINS DEHP

    icumedical

    IM-4446

    ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

    PRINCIPAL DISPLAY PANEL - 500 mL Bag Label
  • INGREDIENTS AND APPEARANCE
    NORMOSOL-R 
    sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0990-7670
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE526 mg  in 100 mL
    SODIUM ACETATE ANHYDROUS (UNII: NVG71ZZ7P0) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM ACETATE ANHYDROUS222 mg  in 100 mL
    SODIUM GLUCONATE (UNII: R6Q3791S76) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM GLUCONATE502 mg  in 100 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE37 mg  in 100 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CHLORIDE30 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0990-7670-0324 in 1 CASE12/31/2019
    1500 mL in 1 BAG; Type 0: Not a Combination Product
    2NDC: 0990-7670-0912 in 1 CASE09/01/2019
    21000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01758609/01/2019
    Labeler - ICU Medical Inc. (118380146)

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