FDA.reportPublic FDA data

Sodium Chloride

Product NDC
0487-9301
11-digit product format
004879301
Labeler code
0487
Product ID
0487-9301_00451b25-f4c3-4c61-a8ce-bee22074a3bd
Type
HUMAN OTC DRUG
Nonproprietary name
ISodium Chloride
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Nephron Pharmaceuticals Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2002-07-18
Marketing end
0000-00-00
Substance
SODIUM CHLORIDE
Active strength
0 mg/3mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage0487-9301-038dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage0487-9301-338dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0487-9301-03e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0487-9301-33e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0487-9301-039bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0487-9301-339bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0487-9301-03110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0487-9301-33110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

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

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XSODIUM CHLORIDE INHALANT [CARDINAL HEALTH]4
SODIUM CATIONACTIVE MOIETYLYR4M0NH37SODIUM CHLORIDE INHALANT [CARDINAL HEALTH]4
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM CHLORIDE INHALANT [CARDINAL HEALTH]4
Sodium ChlorideACTIVE INGREDIENT451W47IQ8XSODIUM CHLORIDE () SODIUM CHLORIDE () SODIUM CHLORIDE () [NEPHRON PHARMACEUTICALS CORPORATION]3
SODIUM CATIONACTIVE MOIETYLYR4M0NH37SODIUM CHLORIDE () SODIUM CHLORIDE () SODIUM CHLORIDE () [NEPHRON PHARMACEUTICALS CORPORATION]3
WaterINACTIVE INGREDIENT059QF0KO0RSODIUM CHLORIDE () SODIUM CHLORIDE () SODIUM CHLORIDE () [NEPHRON PHARMACEUTICALS CORPORATION]3

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312997sodium chloride 0.9 % Inhalation SolutionPSNcebda011-5241-4830-a8b5-96e39ffcdb2e6
312997sodium chloride 9 MG/ML Inhalation SolutionSCDcebda011-5241-4830-a8b5-96e39ffcdb2e6
312997NaCl 9 MG/ML Inhalation SolutionSYcebda011-5241-4830-a8b5-96e39ffcdb2e6
312997sodium chloride 0.9 % Inhalation SolutionSYcebda011-5241-4830-a8b5-96e39ffcdb2e6
312997sodium chloride 0.9 % Inhalation SolutionPSN6a8d9753-fa9a-4429-b0da-a999751c117f3
312997sodium chloride 9 MG/ML Inhalation SolutionSCD6a8d9753-fa9a-4429-b0da-a999751c117f3
312997NaCl 9 MG/ML Inhalation SolutionSY6a8d9753-fa9a-4429-b0da-a999751c117f3
312997sodium chloride 0.9 % Inhalation SolutionSY6a8d9753-fa9a-4429-b0da-a999751c117f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0487-9301-02004879301021 in 1 POUCHHistorical
0487-9301-03004879301033 mL in 1 VIAL, SINGLE-USE3 mlHistorical
0487-9301-330048793013330 in 1 CARTONHistorical