Intended for use in respiratory therapy or for tracheal or lavage. This sterile, single-use device is intended to be used as an accessory to medicinal nonventilatory nebulizers for respiratory therapy or for tracheal irrigation or lavage therapy.
Directions for use: To verify container integrity, squeeze the vial before use. Twist cap completely off vial, invert and squeeze prescribed volume. Discard any unused portion of the contents of this single-use vial as well as any unused solution remaining in the nebulizer cup.
Sodium Chloride, USP
0.9% (0.027 mg per 1 mL)
Sterile, non-pyrogenic, preservative-free single-use vials for respiratory therapy.
No bacteriostatic agent or other preservative added.
Intended for use in respiratory therapy or for tracheal or lavage. This sterile, single-use device is intended to be used as an accessory to medicinal nonventilatory nebulizers for respiratory therapy or for tracheal irrigation or lavage therapy.
Not for injection or in preparations to be used for injection.
This device is not for parenteral use or for preparations intended for parenteral use.
CAUTION: Contents are sterile in the unopened, undamaged package.
Directions for use: To verify container integrity, squeeze the vial before use. Twist cap completely off vial, invert and squeeze prescribed volume.
Discard any unused portion of the contents of this single-use vial as well as any unused solution remaining in the nebulizer cup.
Keep out of reach of children.
RX ONLY
Water for Injection, USP
Sodium Chloride Inhalation Solution, 0.9% is supplied in single-use plastic vials in the following configurations.
NDC 55154-4358-5 overbagged with 5 x 3 mL vial per bag
Internal contents sterile. External surface of vial not sterile.
Store at controlled room temperature 15° to 30°C (59° to 86°F).
Nephron Pharmaceuticals Corporation
West Columbia, SC 29172
For Customer Service, Call 1-800-443-4313
Email: Customerservice@nephronpharm.com
Made in the USA
Distributed By:
Cardinal Health
Dublin, OH 43017
L44920210519
Sodium Chloride
Inhalation Solution, USP, 0.9%
5 x 3 ml Unit-Dose Vials
Each in a foil pouch
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0487-9301-02 | ML - Milliliter | 0487-9301 | cb6c769b-e99b-4f10-9142-13701eb9f3b6 | 1 | 2014-10-03 |
| 0487-9301-03 | ML - Milliliter | 0487-9301 | 5bd15fee-d5cf-4ef7-8720-14bf9f4074b2 | 1 | 2012-07-24 |
| 0487-9301-33 | ML - Milliliter | 0487-9301 | 22775411-6179-4360-8601-e12040dd2b81 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SODIUM CHLORIDE | ACTIVE INGREDIENT | 451W47IQ8X | 4 | |
| SODIUM CATION | ACTIVE MOIETY | LYR4M0NH37 | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55154-4358 | 55154-4358-5 |
| 0487-9301 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM CHLORIDE | 451W47IQ8X | ACTIB |
| WATER | 059QF0KO0R | IACT |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2bd40a34-c13c-47e1-9e12-aea138f988ed | 8f14bf79-c6ee-4f4f-8540-1941d7fe3241 | 2022-12-15 | Warnings | 2bd40a34-c13c-47e1-9e12-aea138f988ed 8f14bf79-c6ee-4f4f-8540-1941d7fe3241 |
Adverse event summaries are temporarily unavailable. Other product information remains available.