Sodium Chloride
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Effective date
- 2016-12-02
- Label type
- MEDICAL DEVICE
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 02:49:50
Label at a glance#
ProductSodium Chloride
Active ingredientSODIUM CHLORIDE
Label structure3 sections
Contacts and useful links#
Label contents#
Full prescribing information#
Sodium Chloride Inhalation Solution 0.9% 3 mL
PRODUCT CODE 0378-6985-01
Sodium Chloride
Inhalation Solution, USP
0.9% 3 mL
For Respiratory Therapy
Not for Parenteral Administration.
100 x 3 mL
Sterile Unit-Dose Vials
Sodium Chloride Inhalation Solution, USP
0.9% 3 mL
Sterile, non-pyrogenic, preservative-free single-use vials for respiratory therapy. No bacteriostatic agent or other preservative added.
INDICATIONS: Contents of these vials are for use in respiratory therapy and for tracheal irrigation or lavage.
WARNING: Not for injection or in preparations to be used for injection.
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.
HOW SUPPLIED: Single-use plastic vials containing 3 mL or 5 mL solutions supplied in cartons of 100 vials and 15 mL solution supplied in cartons of 50 vials.
PRODUCT CODE 0378-6985-01 Sodium Chloride Inhalation Solution, USP 0.9%, 3 mL
PRODUCT CODE 0378-6986-01 Sodium Chloride Inhalation Solution, USP 0.9%, 5 mL
PRODUCT CODE 0378-6987-89 Sodium Chloride Inhalation Solution, USP 0.9%, 15 mL
Internal contents sterile. External surface of vial not sterile.
STORAGE: Store at controlled room temperature 15° to 30°C (59° to 86°F).
Rx only
For more information, call Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).
Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Manufactured by: The Ritedose Corporation Columbia, SC 29203
TRC:6985:100C:R3
Sodium Chloride Inhalation Solution 0.9% 5 mL
PRODUCT CODE 0378-6986-01
Sodium Chloride
Inhalation Solution, USP
0.9% 5 mL
For Respiratory Therapy
Not for Parenteral Administration.
100 x 5 mL
Sterile Unit-Dose Vials
Sodium Chloride Inhalation Solution, USP
0.9% 5 mL
Sterile, non-pyrogenic, preservative-free single-use vials for respiratory therapy. No bacteriostatic agent or other preservative added.
INDICATIONS: Contents of these vials are for use in respiratory therapy and for tracheal irrigation or lavage.
WARNING: Not for injection or in preparations to be used for injection.
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.
HOW SUPPLIED: Single-use plastic vials containing 3 mL or 5 mL solutions supplied in cartons of 100 vials and 15 mL solution supplied in cartons of 50 vials.
PRODUCT CODE 0378-6985-01 Sodium Chloride Inhalation Solution, USP 0.9%, 3 mL
PRODUCT CODE 0378-6986-01 Sodium Chloride Inhalation Solution, USP 0.9%, 5 mL
PRODUCT CODE 0378-6987-89 Sodium Chloride Inhalation Solution, USP 0.9%, 15 mL
Internal contents sterile. External surface of vial not sterile.
STORAGE: Store at controlled room temperature 15° to 30°C (59° to 86°F).
Rx only
For more information, call Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).
Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Manufactured by: The Ritedose Corporation Columbia, SC 29203
TRC:6986:100C:R3
Sodium Chloride Inhalation Solution 0.9% 15 mL
PRODUCT CODE 0378-6987-89
Sodium Chloride
Inhalation Solution, USP
0.9% 15 mL
For Respiratory Therapy
Not for parenteral administration.
50 x 15 mL
Sterile Unit-Dose Vials
Sodium Chloride Inhalation Solution, USP
0.9% 15 mL
Sterile, non-pyrogenic, preservative-free single-use vials for respiratory therapy. No bacteriostatic agent or other preservative added.
INDICATIONS: Contents of these vials are for use in respiratory therapy and for tracheal irrigation or lavage.
WARNING: Not for injection or in preparations to be used for injection.
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.
HOW SUPPLIED: Single-use plastic vials containing 3 mL or 5 mL solutions supplied in cartons of 100 vials and 15 mL solution supplied in cartons of 50 vials.
PRODUCT CODE 0378-6985-01 Sodium Chloride Inhalation Solution, USP 0.9%, 3 mL
PRODUCT CODE 0378-6986-01 Sodium Chloride Inhalation Solution, USP 0.9%, 5 mL
PRODUCT CODE 0378-6987-89 Sodium Chloride Inhalation Solution, USP 0.9%, 15 mL
Internal contents sterile. External surface of vial not sterile.
STORAGE: Store at controlled room temperature 15° to 30°C (59° to 86°F).
Rx only
For more information, call Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).
Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 Manufactured by: The Ritedose Corporation Columbia, SC 29203
TRC:6987:50C:R3
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| SODIUM CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0378-6985-01 | Sodium Chloride | 100 in 1 CARTON | 100 | 4 | ||
| 0378-6985-01 | Sodium Chloride | 3 mL in 1 VIAL | 3 | 4 | ||
| 0378-6986-01 | Sodium Chloride | 100 in 1 CARTON | 100 | 4 | ||
| 0378-6986-01 | Sodium Chloride | 5 mL in 1 VIAL | 5 | 4 | ||
| 0378-6987-89 | Sodium Chloride | 50 in 1 CARTON | 50 | 4 | ||
| 0378-6987-89 | Sodium Chloride | 15 mL in 1 VIAL | 15 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0378-6985 | SODIUM CHLORIDE () SODIUM CHLORIDE () SODIUM CHLORIDE () [MYLAN PHARMACEUTICALS INC.] | 4 | 2 package rows | 20210116_d4ec61e7-c506-43bb-88cf-e75e4dd64e1b.zip |
| 0378-6986 | SODIUM CHLORIDE () SODIUM CHLORIDE () SODIUM CHLORIDE () [MYLAN PHARMACEUTICALS INC.] | 4 | 2 package rows | 20210116_d4ec61e7-c506-43bb-88cf-e75e4dd64e1b.zip |
| 0378-6987 | SODIUM CHLORIDE () SODIUM CHLORIDE () SODIUM CHLORIDE () [MYLAN PHARMACEUTICALS INC.] | 4 | 2 package rows | 20210116_d4ec61e7-c506-43bb-88cf-e75e4dd64e1b.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-6985-01 | ML - Milliliter | 0378-6985 | 24026086-77ef-40eb-a49f-c7d4cb1ddad8 | 1 | 2013-02-19 |
| 0378-6986-01 | ML - Milliliter | 0378-6986 | 690d6dc9-ee93-46ee-8c75-c8dc2d0c1d25 | 1 | 2013-02-19 |
| 0378-6987-89 | ML - Milliliter | 0378-6987 | 206df48d-8003-4ea2-9285-f8c45805974e | 1 | 2013-02-19 |
Products#
Every source-derived product name is available through these pages.
- Sodium Chloride
- SODIUM CATION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0378-6985 | 0378-6985-01 |
| 0378-6986 | 0378-6986-01 |
| 0378-6987 | 0378-6987-89 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM CHLORIDE | 451W47IQ8X | ACTIB |
| SODIUM CHLORIDE | 451W47IQ8X | ACTIB |
| SODIUM CHLORIDE | 451W47IQ8X | ACTIB |
Source Document#
openFDA label cross-check#
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.