Sodium Chloride Inhalation Solution, USP 0.9%

Manufacturer
Nephron Pharmaceuticals Corporation
Effective date
2015-01-30
Label type
MEDICAL DEVICE
Version
3
Source
full-release
Hydrated at
2026-06-01 02:48:03

Label at a glance#

ProductSodium Chloride
Active ingredientSodium Chloride
Label structure3 sections

Label contents#

Full prescribing information#

Sodium Chloride Inhalation Solution, USP 0.9% 3 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0487-9301-33

Sodium Chloride
Inhalation Solution, USP 0.9%

Sterile, non-pyrogenic, preservative-free
single-use vials for respiratory therapy.

No bacteriostatic agent or other
preservative added.

MADE
IN THE
USA

For Respiratory Therapy
Not for parenteral administration.

nephron
pharmaceuticals
corporation
Orlando, FL 32811

30 × 3 mL Sterile Unit-Dose Vials, each in a foil pouch.

INDICATIONS: 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.

This device is not intended for parenteral use or for preparations intended for parenteral use.

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: Sodium Chloride Inhalation Solution, USP 0.9% is supplied in single-use plastic vials in the following configurations:

NDC 0487-9301-03 3 mL, 100 vials per carton
NDC 0487-9301-33 3 mL, 30 vials per carton / 1 vial per foil pouch
NDC 0487-9301-02 3 mL, 30 vials per carton / 1 vial per foil pouch / robot ready
NDC 0487-9302-01 5 mL, 100 vials per carton
NDC 0487-9315-30 15 mL, 30 vials per carton

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

Please Recycle

IC 426
Rev. 09-23-14

Sodium Chloride Inhalation Solution, USP 0.9% 3 mL
Sodium Chloride Inhalation Solution, USP 0.9% 3 mL

Sodium Chloride Inhalation Solution, USP 0.9% 5 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0487-9302-01

Sodium Chloride
Inhalation Solution, USP 0.9%

Sterile, non-pyrogenic, preservative-free
single-use vials for respiratory therapy.

No bacteriostatic agent or other preservative
added.

For Respiratory Therapy
Not for parenteral administration.

100 × 5 mL Sterile Unit-Dose Vials

Manufactured By:
nephron
pharmaceuticals
corporation
Orlando, FL 32811

INDICATIONS: 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.

This device is not intended for parenteral use or for preparations intended for parenteral use.

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: Sodium Chloride Inhalation Solution, USP 0.9% is supplied in single-use plastic vials in the following configurations:

NDC 0487-9301-03 3 mL, 100 vials per carton
NDC 0487-9301-33 3 mL, 30 vials per carton / 1 vial per foil pouch
NDC 0487-9301-02 3 mL, 30 vials per carton / 1 vial per foil pouch / robot ready
NDC 0487-9302-01 5 mL, 100 vials per carton
NDC 0487-9315-30 15 mL, 30 vials per carton

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

Please Recycle

IC 440
Rev. 09-23-14

Sodium Chloride Inhalation Solution, USP 0.9% 5 mL
Sodium Chloride Inhalation Solution, USP 0.9% 5 mL

Sodium Chloride Inhalation Solution, USP 0.9% 15 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0487-9315-30

Sodium Chloride
Inhalation Solution, USP 0.9%

Sterile, non-pyrogenic, preservative-free single-use vials for
respiratory therapy.

No bacteriostatic agent or other preservative added.

For Respiratory Therapy
Not for parenteral administration.

30 × 15 mL Sterile Unit-Dose Vials

Manufactured By:
nephron
pharmaceuticals
corporation
Orlando, FL 32811

MADE
IN THE
USA

INDICATIONS: 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.

This device is not intended for parenteral use or for preparations intended for parenteral use.

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: Sodium Chloride Inhalation Solution, USP 0.9% is supplied in single-use plastic vials in the following packaging configurations:

NDC 0487-9301-03 3 mL, 100 vials per carton
NDC 0487-9301-33 3 mL, 30 vials per carton / 1 vial per foil pouch
NDC 0487-9301-02 3 mL, 30 vials per carton / 1 vial per foil pouch / robot ready
NDC 0487-9302-01 5 mL, 100 vials per carton
NDC 0487-9315-30 15 mL, 30 vials per carton

STORAGE: Store at controlled room temperature 15° to 30°C (59° to 86°F).

Internal contents sterile. External surface of vial not sterile.
Rx Only

IC 446
Rev. 08-27-14

Sodium Chloride Inhalation Solution, USP 0.9% 15 mL
Sodium Chloride Inhalation Solution, USP 0.9% 15 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312997sodium chloride 0.9 % Inhalation SolutionPSN3
312997sodium chloride 9 MG/ML Inhalation SolutionSCD3
312997NaCl 9 MG/ML Inhalation SolutionSY3
312997sodium chloride 0.9 % Inhalation SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0487-9301-032019-11-13C16284748780-197449f38-bcb4-f6ea-e053-dbdaa90aa703Sodium Chloride Inhalation Solution, USP 0.9%
0487-9301-332019-11-13C16284748780-197449f38-bcb4-f6ea-e053-dbdaa90aa703Sodium Chloride Inhalation Solution, USP 0.9%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0487-9301-02Sodium Chloride1 in 1 POUCH13
0487-9301-02Sodium Chloride1 in 1 BAG13
0487-9301-03Sodium Chloride3 mL in 1 VIAL, SINGLE-USE33
0487-9301-03Sodium Chloride100 in 1 CARTON1003
0487-9301-33Sodium Chloride30 in 1 CARTON303
0487-9301-33Sodium Chloride1 in 1 POUCH13
0487-9302-01Sodium Chloride5 mL in 1 VIAL, SINGLE-USE53
0487-9302-01Sodium Chloride100 in 1 CARTON1003
0487-9315-30Sodium Chloride30 in 1 CARTON303
0487-9315-30Sodium Chloride15 mL in 1 VIAL, SINGLE-USE153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0487-9301SODIUM CHLORIDE () SODIUM CHLORIDE () SODIUM CHLORIDE () [NEPHRON PHARMACEUTICALS CORPORATION]3Legacy NDC, 6 package rows20150317_6a8d9753-fa9a-4429-b0da-a999751c117f.zip
0487-9302SODIUM CHLORIDE () SODIUM CHLORIDE () SODIUM CHLORIDE () [NEPHRON PHARMACEUTICALS CORPORATION]32 package rows20150317_6a8d9753-fa9a-4429-b0da-a999751c117f.zip
0487-9315SODIUM CHLORIDE () SODIUM CHLORIDE () SODIUM CHLORIDE () [NEPHRON PHARMACEUTICALS CORPORATION]32 package rows20150317_6a8d9753-fa9a-4429-b0da-a999751c117f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0487-9301-02ML - Milliliter0487-9301cb6c769b-e99b-4f10-9142-13701eb9f3b612014-10-03
0487-9301-03ML - Milliliter0487-93015bd15fee-d5cf-4ef7-8720-14bf9f4074b212012-07-24
0487-9301-33ML - Milliliter0487-930122775411-6179-4360-8601-e12040dd2b8112012-07-24
0487-9302-01ML - Milliliter0487-93020c7ac87b-4a51-4694-9581-c9ee7ad593fb12014-10-03
0487-9315-30ML - Milliliter0487-93153cf85396-1be9-4e20-912c-5f93a1e9b07412015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Sodium ChlorideACTIVE INGREDIENT451W47IQ8X3
SODIUM CATIONACTIVE MOIETYLYR4M0NH373
WaterINACTIVE INGREDIENT059QF0KO0R3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML · Source PDF

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
00451b25-f4c3-4c61-a8ce-bee22074a3bd6a8d9753-fa9a-4429-b0da-a999751c117f2012-01-20WarningsExact identifier
spl set id: 6a8d9753-fa9a-4429-b0da-a999751c117f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.