Sodium Chloride 9 mg/mL Injection — NDC 0641-0497-25 (Billing 00641-0497-25)
This is a package of Sodium Chloride 9 mg/mL Injection from Hikma Pharmaceuticals USA Inc., marketed since Sep 2013 and currently FDA-listed. It is this product's only package size.
Other active recalls for Sodium Chloride (different manufacturers) — 6 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 001221
- GCN: 03034
- GPI-14 (Medi-Span): 79750010002018
- HICL (First Databank): 008255
- AHFS class code: 40:12.00.00
- RxCUI (RxNorm): 1807636
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Sodium class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It depends on the product. IV forms replace fluid and salt, while injection diluents dissolve other drugs. Other forms are used for rinsing, nasal congestion and nasal care, or to...
- Follow the directions on your product. Many are used as often as needed by adults and children 4 and over. Do not share the bottle, because that can spread infection.
- Some people get fever, irritation or infection at the IV site, or too much fluid in the body. Tell your nurse right away if the IV site hurts or looks red.
- What side effects should I expect with IV sodium chloride?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Sodium Chloride — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.2108 | $5.27 / 25 vials |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00641-0497-25 You're viewing this Main listing | 25 VIAL in 1 CARTON / 2 mL in 1 VIAL | 2013-09-24 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Bacteriostatic Sodium Chloride 9 mg/mL 00409-1966-05 | Hospira, | 25 vials | $0.067 | AP | Availability likely | — |
| Sodium Chloride 9 mg/mL 00409-4888-10 | Hospira, | 25 vials | $0.089 | AP | Availability likely | — |
| Sodium Chloride 9 mg/mLthis 00641-0497-25 | Hikma | 25 vials | — | — | FDA listed | — |
| Sodium Chloride 9 mg/mL 63323-0186-02 | Fresenius | 25 vials | — | — | FDA listed | — |
| Sodium Chloride 9 mg/mL 71872-7248-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Sodium Chloride 9 mg/mL 76420-0083-10 | Asclemed | 10 ml | — | AP | FDA listed | — |
| Bacteriostatic Sodium Chloride 9 mg/mL 71872-7083-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Sodium Chloride 9 mg/mL 51662-1464-01 | HF | 20 ml | — | AP | FDA listed | — |
| Sodium Chloride 9 mg/mL 55154-0126-05 | Cardinal | 5 vials | — | AP | Discontinued | — |
| Sodium Chloride 9 mg/mL 00404-9954-20 | Henry | 1 vial | — | AP | FDA listed | — |
| Bacteriostatic Sodium Chloride 9 mg/mL 00404-9953-10 | Henry | 1 vial | — | AP | FDA listed | — |
| Sodium Chloride 9 mg/mL 84549-0888-10 | ProPharma | 10 ml | — | AP | FDA listed | — |
| Bacteriostatic Sodium Chloride 9 mg/mL 63323-0924-10 | Fresenius | 25 vials | — | AP | FDA listed | — |
| sodium chloride 9 mg/mL 64253-0202-30 | Medefil, | 60 syringes | — | — | FDA listed | — |
| Sodium Chloride 9 mg/mL 00641-6144-25 | Hikma | 25 vials | — | — | FDA listed | — |
| Bacteriostatic Sodium Chloride 9 mg/mL 84549-0966-07 | ProPharma | 30 ml | — | AP | FDA listed | — |
| Sodium Chloride 9 mg/mL 65282-1505-01 | Spectra | 5 ampules | — | AP | FDA listed | — |
| Sodium Chloride 9 mg/mL 51662-1342-01 | HF | 10 ml | — | AP | FDA listed | — |
| Sodium Chloride 9 mg/mL 65282-1510-01 | Spectra | 5 ampules | — | AP | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
-
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE This parenteral preparation indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.
🔄 Drug Interactions ▾
Drug Interactions Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available. Use aseptic technique for entry and withdrawal from all containers.
When diluting or dissolving drugs, mix thoroughly and use promptly. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Do not use unless the solution is clear and seal intact.
Do not reuse single dose containers, discard unused portion.
🤰 Pregnancy ▾
Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with Sodium Chloride Injection USP, 0.9%. It is also not known whether sodium chloride injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium chloride injection containing additives should be given to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.
🆘 Overdosage ▾
OVERDOSAGE Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of carbohydrate, sodium chloride or fluid overload except possibly in neonates or very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. See PRECAUTIONS and ADVERSE REACTIONS .
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Sodium chloride in water dissociates to provide sodium (Na + ) and chloride (Cl – ) ions. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. 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.
The small volume of fluid and amount of sodium chloride provided by Sodium Chloride Injection USP, 0.9% when used only as an isotonic vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in neonates and very small infants. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges 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.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Sodium Chloride Injection USP, 0.9% is supplied in the following: 2 mL vials packaged in carton of 25 vials (NDC 0641-0497-25) 10 mL vials packaged in carton of 25 vials (NDC 0641-6144-25) Storage Store at 20° - 25°C (68°-77°F), excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature]. Avoid freezing.
📋 Description ▾
DESCRIPTION This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. Sodium Chloride Injection USP, 0.9% is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each mL contains sodium chloride 9 mg.
It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. Its chloride and sodium ion concentrations are approximately 0.154 mEq of each per milliliter and its calculated osmolality is 0.308 milliosmols per mL. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment, pH 5.3 (4.5 to 7.0).
Sodium chloride, USP occurs as colorless cubic crystals or white crystalline powder and has a saline taste. Sodium chloride is freely soluble in water. The empirical formula for sodium chloride is NaCl, and the molecular weight is 58.44.
⚠️ Precautions ▾
PRECAUTIONS General Consult the manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with Sodium Chloride Injection USP, 0.9%.
It is also not known whether sodium chloride injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium chloride injection containing additives should be given to a pregnant woman only if clearly needed. Pediatric Use The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations.
In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. Drug Interactions Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available.
Use aseptic technique for entry and withdrawal from all containers. When diluting or dissolving drugs, mix thoroughly and use promptly. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute.
Do not use unless the solution is clear and seal intact. Do not reuse single dose containers, discard unused portion.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 0641- 0497 -17 Rx only Sodium Chloride Injection USP, 0.9% 0.308 mOsmol/mL Preservative Free For use as a sterile diluent 2 mL Single Dose Vial NDC 0641- 0497 -25 Rx only Sodium Chloride Injection USP, 0.9% 0.308 mOsmol/mL Preservative Free For use as a sterile diluent 25 x 2 mL Single Dose Vials vial shelfpack
PRINCIPAL DISPLAY PANEL NDC 0641-6144-01 Rx only Sodium Chloride Injection USP, 0.9% 0.308 mOsmol/mL PRESERVATIVE-FREE For use as a sterile diluent 10 mL Single Dose Vial Each mL contains sodium chloride 9 mg in Water for Injection; pH 4.5-7.0, may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Sterile, nonpyrogenic. Contains no preservative.
Discard unused portion. For additional information, see package insert. Store at 20º-25ºC (68º-77ºF) [See USP Controlled Room Temperature].
NDC 0641-6144-25 Rx only Sodium Chloride Injection USP, 0.9% 0.308 mOsmol/mL PRESERVATIVE-FREE For use as a sterile diluent 25 x 10 mL Single Dose Vials Each mL contains sodium chloride 9 mg in Water for Injection; pH 4.5-7.0, may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Sterile, nonpyrogenic. Contains no preservative.
Discard unused portion. For additional information, see package insert. Store at 20º-25ºC (68º-77ºF) [See USP Controlled Room Temperature].
NDC 0641-6144-01 Rx only Sodium Chloride Injection USP, 0.9% 0.308 mOsmol/mL PRESERVATIVE-FREE For use as a sterile diluent 10 mL Single Dose Vial Each mL contains sodium chloride 9 mg in Water for Injection; pH 4.5-7.0, may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Sterile, nonpyrogenic. Contains no preservative.
Discard unused portion. For additional information, see package insert. Store at 20º-25ºC (68º-77ºF) [See USP Controlled Room Temperature].
NDC 0641-6144-25 Rx only Sodium Chloride Injection USP, 0.9% 0.308 mOsmol/mL PRESERVATIVE-FREE For use as a sterile diluent 25 x 10 mL Single Dose Vials Each mL contains sodium chloride 9 mg in Water for Injection; pH 4.5-7.0, may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Sterile, nonpyrogenic. Contains no preservative.
Discard unused portion. For additional information, see package insert. Store at 20º-25ºC (68º-77ºF) [See USP Controlled Room Temperature].
Medicaid utilization & spend
Medicare Part D spend CMS · PART D · 2026 (Q1)
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |