Label: SODIUM CHLORIDE injection, solution

  • NDC Code(s): 0990-7730-36, 0990-7730-37, 0990-7983-02, 0990-7983-03, view more
    0990-7983-09, 0990-7983-53, 0990-7983-55, 0990-7983-61, 0990-7984-13, 0990-7984-20, 0990-7984-23, 0990-7984-36, 0990-7984-37, 0990-7985-02, 0990-7985-03, 0990-7985-09
  • Packager: ICU Medical Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 11, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Flexible Plastic Container                                                                                                               Rx only

  • DESCRIPTION

    Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of sodium chloride in water for injection intended for intravenous administration.

    For 0.45% Sodium Chloride Injection, USP, each 100 mL contains 450 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 77 mEq; chloride 77 mEq. The osmolarity is 154 mOsmol/L (calc.).

    For 0.9% Sodium Chloride Injection, USP, each 100 mL contains 900 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.).

    The pH for both concentrations in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers.

    The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded.

    The solutions are parenteral fluid and electrolyte replenishers.

    Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.

    Water for Injection, USP is chemically designated H2O.

    The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

  • CLINICAL PHARMACOLOGY

    When administered intravenously, these solutions provide a source of water and electrolytes.

    Solutions which provide combinations of hypotonic or isotonic concentrations of sodium chloride are suitable for parenteral maintenance or replacement of water and electrolyte requirements.

    Isotonic concentrations of sodium chloride are suitable for parenteral replacement of chloride losses that exceed or equal the sodium loss. Hypotonic concentrations of sodium chloride are suited for parenteral maintenance of water requirements when only small quantities of salt are desired. A hypertonic concentration of sodium chloride may be used to repair severe salt depletion syndrome.

    Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl) ions. Sodium (Na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na+) and chloride (Cl) are largely under the control of the kidney which maintains a balance between intake and output.

    Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirements range from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

    Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

  • INDICATIONS AND USAGE

    Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.

  • CONTRAINDICATIONS

    None known.

  • WARNINGS

    Sodium Chloride Injection, USP should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.

    The intravenous administration of Sodium Chloride Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

    The risk of dilutive states is inversely proportional to the electrolyte concentration of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections.

    In patients with diminished renal function, administration of Sodium Chloride Injection, USP may result in sodium retention.

  • PRECAUTIONS

    General

    Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

    Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.

    Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

    Laboratory Tests

    Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

  • DRUG INTERACTIONS

    Caution must be exercised in the administration of Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin.

    Carcinogenesis, Mutagenesis, Impairment of Fertility 

    Studies have not been performed with Sodium Chloride Injection, USP to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility.

    Pregnancy:

    Teratogenic Effects

    Pregnancy Category C 

    Animal reproduction studies have not been conducted with Sodium Chloride Injection, USP. It is also not known whether Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Injection, USP should be given to a pregnant woman only if clearly needed.

    Labor and Delivery

    Studies have not been conducted to evaluate the effects of Sodium Chloride Injection, USP on labor and delivery. Caution should be exercised when administering this drug during labor and delivery.

    Nursing Mothers

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sodium Chloride Injection, USP is administered to a nursing mother.

    Pediatric Use

    The use of Sodium Chloride Injection, USP in pediatric patients is based on clinical practice.

    Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes.

    The infusion of hypotonic fluids (0.45% Sodium Chloride Injection, USP) together with the non-osmotic secretion of ADH may result in hyponatremia in patients with acute volume depletion. Hyponatremia can lead to headache, nausea, seizures, lethargy, coma, cerebral edema and death, therefore acute symptomatic hyponatremic encephalopathy is considered a medical emergency.

    Geriatric Use

    Clinical studies of Sodium Chloride Injection, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.

    This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

    Do not administer unless solution is clear and container is undamaged. Discard unused portion.

  • ADVERSE REACTIONS

    Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

    If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

    In addition to the above listed adverse reactions hyponatremia has been reported for 0.45% Sodium Chloride Injection, USP (see Pediatric Use section).

  • OVERDOSAGE

    In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. (See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.)

  • DOSAGE AND ADMINISTRATION

    The dose is dependent upon the age, weight and clinical condition of the patient.

    Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS.)

  • INSTRUCTIONS FOR USE

    To Open

    Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

    To Add Medication

    1.
    Prepare additive port.
    2.
    Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication.
    3.
    The additive port may be protected by covering with an additive cap.
    4.
    Mix container contents thoroughly.

    Preparation for Administration

    (Use aseptic technique)

    1.
    Close flow control clamp of administration set.
    2.
    Remove cover from outlet port at bottom of container.
    3.
    Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: See full directions on administration set carton.
    4.
    Suspend container from hanger.
    5.
    Squeeze and release drip chamber to establish proper fluid level in chamber.
    6.
    Open flow control clamp and clear air from set. Close clamp.
    7.
    Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.
    8.
    Regulate rate of administration with flow control clamp.

    WARNING: Do not use flexible container in series connections.

  • HOW SUPPLIED

    Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers in various sizes and concentrations as shown in the accompanying Table.

    NDC No.ProductContainer size mL
    *
    Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA
    Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

    0409-7730-36*

    0.45% Sodium Chloride Inj., USP

    50

    0990-7730-36*

    0.45% Sodium Chloride Inj., USP

    50

    0409-7730-37*

    0.45% Sodium Chloride Inj., USP

    100

    0990-7730-37*

    0.45% Sodium Chloride Inj., USP

    100

    0409-7985-02*

    0.45% Sodium Chloride Inj., USP

    250

    0990-7985-02*

    0.45% Sodium Chloride Inj., USP

    250

    0409-7985-03

    0.45% Sodium Chloride Inj., USP

    500

    0990-7985-03*,

    0.45% Sodium Chloride Inj., USP

    500

    0409-7985-09*,

    0.45% Sodium Chloride Inj., USP

    1000

    0990-7985-09*,

    0.45% Sodium Chloride Inj., USP

    1000

    0409-7984-20*

    0.9% Sodium Chloride Inj., USP

    25

    0990-7984-20*

    0.9% Sodium Chloride Inj., USP

    25

    0409-7984-36*

    0.9% Sodium Chloride Inj., USP

    50

    0990-7984-36*

    0.9% Sodium Chloride Inj., USP

    50

    0409-7984-13*

    0.9% Sodium Chloride Inj., USP

    50

    0990-7984-13*

    0.9% Sodium Chloride Inj., USP

    50

    0409-7984-37*

    0.9% Sodium Chloride Inj., USP

    100

    0990-7984-37*

    0.9% Sodium Chloride Inj., USP

    100

    0409-7984-23*

    0.9% Sodium Chloride Inj., USP

    100

    0990-7984-23*

    0.9% Sodium Chloride Inj., USP

    100

    0409-7983-61*

    0.9% Sodium Chloride Inj., USP

    150

    0990-7983-61*

    0.9% Sodium Chloride Inj., USP

    150

    0409-7983-02*,

    0.9% Sodium Chloride Inj., USP

    250

    0990-7983-02*,

    0.9% Sodium Chloride Inj., USP

    250

    0409-7983-53

    0.9% Sodium Chloride Inj., USP

    250

    0990-7983-53

    0.9% Sodium Chloride Inj., USP

    250

    0409-7983-03

    0.9% Sodium Chloride Inj., USP

    500

    0990-7983-03*,

    0.9% Sodium Chloride Inj., USP

    500

    0409-7983-55*

    0.9% Sodium Chloride Inj., USP

    500

    0990-7983-55*

    0.9% Sodium Chloride Inj., USP

    500

    0409-7983-09*,

    0.9% Sodium Chloride Inj., USP

    1000

    0990-7983-09*,

    0.9% Sodium Chloride Inj., USP

    1000

    ICU Medical is transitioning NDC codes from "0409" to "0990" labeler code. Both NDC codes are expected to be in the market for a period of time.

    Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

    Revised: April, 2020

    IFU0000188

  • PRINCIPAL DISPLAY PANEL - 50 mL Bag Label

    50 mL
    NDC 0990-7730-36

    0.45% SODIUM CHLORIDE
    INJECTION, USP

    EACH 100 mL CONTAINS SODIUM CHLORIDE
    450 mg IN WATER FOR INJECTION. ELECTROLYTES
    PER 1000 mL: SODIUM 77 mEq; CHLORIDE 77 mEq.
    154 mOsmol/LITER (CALC.) pH 6.0 (4.5 to 7.0)
    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 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

    IM-4346

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

    icumedical

    PRINCIPAL DISPLAY PANEL - 50 mL Bag Label
  • PRINCIPAL DISPLAY PANEL - 250 mL Bag Label

    250 mL
    NDC 0990-7983-53

    0.9% SODIUM CHLORIDE
    INJECTION, USP

    EACH 100 mL CONTAINS SODIUM
    CHLORIDE 900 mg IN WATER FOR
    INJECTION. ELECTROLYTES PER 1000 mL:
    SODIUM 154 mEq; CHLORIDE 154 mEq.
    308 mOsmol/LITER (CALC).
    pH 5.6 (4.5 to 7.0)
    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 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

    IM-4450

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

    icumedical

    PRINCIPAL DISPLAY PANEL - 250 mL Bag Label
  • PRINCIPAL DISPLAY PANEL - 25 mL Bag Label

    25 mL
    NDC 0990-7984-20

    0.9% SODIUM CHLORIDE
    Injection, USP

    EACH 100 mL CONTAINS SODIUM CHLORIDE,
    900 mg. ELECTROLYTES (mEq/LITER): SODIUM,
    154 mEq; CHLORIDE, 154 mEq. 308 mOsmol/LITER
    (CALC). pH 6.0 (4.5 to 7.0). ADDITIVES MAY BE
    INCOMPATIBLE. SINGLE-DOSE CONTAINER. FOR
    I.V. 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

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

    icumedical

    IM-4350

    PRINCIPAL DISPLAY PANEL - 25 mL Bag Label
  • PRINCIPAL DISPLAY PANEL - 500 mL Bag Label

    500 mL
    NDC 0990-7985-03

    0.45% Sodium Chloride
    Injection, USP

    EACH 100 mL CONTAINS SODIUM CHLORIDE 450 mg IN
    WATER FOR INJECTION. ELECTROLYTES PER 1000 mL:
    SODIUM 77 mEq; CHLORIDE 77 mEq.

    154 mOsmol/LITER (CALC.)
    pH 5.6 (4.5 to 7.0)

    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 I.V. 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-4391

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

    PRINCIPAL DISPLAY PANEL - 500 mL Bag Label
  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE 
    sodium chloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0990-7730
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE450 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0990-7730-3620 in 1 CASE12/31/2019
    14 in 1 POUCH
    150 mL in 1 BAG; Type 0: Not a Combination Product
    2NDC:0990-7730-3720 in 1 CASE12/31/2019
    24 in 1 POUCH
    2100 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01809004/01/2019
    SODIUM CHLORIDE 
    sodium chloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0990-7983
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE900 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0990-7983-6132 in 1 CASE11/01/2019
    11 in 1 POUCH
    1150 mL in 1 BAG; Type 0: Not a Combination Product
    2NDC:0990-7983-0224 in 1 CASE05/01/2019
    21 in 1 POUCH
    2250 mL in 1 BAG; Type 0: Not a Combination Product
    3NDC:0990-7983-0324 in 1 CASE12/31/2019
    31 in 1 POUCH
    3500 mL in 1 BAG; Type 0: Not a Combination Product
    4NDC:0990-7983-0912 in 1 CASE11/15/2019
    41 in 1 POUCH
    41000 mL in 1 BAG; Type 0: Not a Combination Product
    5NDC:0990-7983-5518 in 1 CASE12/31/2019
    51 in 1 POUCH
    5500 mL in 1 BAG; Type 0: Not a Combination Product
    6NDC:0990-7983-5324 in 1 CASE12/31/2019
    61 in 1 POUCH
    6250 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01636604/01/2019
    SODIUM CHLORIDE 
    sodium chloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0990-7984
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE900 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0990-7984-3720 in 1 CASE05/01/2019
    14 in 1 POUCH
    1100 mL in 1 BAG; Type 0: Not a Combination Product
    2NDC:0990-7984-2012 in 1 CASE11/01/2019
    24 in 1 POUCH
    225 mL in 1 BAG; Type 0: Not a Combination Product
    3NDC:0990-7984-1348 in 1 CASE05/01/2019
    31 in 1 POUCH
    350 mL in 1 BAG; Type 0: Not a Combination Product
    4NDC:0990-7984-2348 in 1 CASE04/01/2019
    41 in 1 POUCH
    4100 mL in 1 BAG; Type 0: Not a Combination Product
    5NDC:0990-7984-3620 in 1 CASE05/01/2019
    54 in 1 POUCH
    550 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01636604/01/2019
    SODIUM CHLORIDE 
    sodium chloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0990-7985
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE450 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0990-7985-0224 in 1 CASE10/15/2019
    11 in 1 POUCH
    1250 mL in 1 BAG; Type 0: Not a Combination Product
    2NDC:0990-7985-0324 in 1 CASE12/31/2019
    21 in 1 POUCH
    2500 mL in 1 BAG; Type 0: Not a Combination Product
    3NDC:0990-7985-0912 in 1 CASE11/01/2019
    31 in 1 POUCH
    31000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01809004/01/2019
    Labeler - ICU Medical Inc. (118380146)