FDA.reportPublic FDA data

Sodium Chloride

Product NDC
0338-0047
11-digit product format
003380047
Labeler code
0338
Product ID
0338-0047_c40dacc6-de2f-4a7f-af42-26501eff74b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Chloride
Dosage form
IRRIGANT
Route
IRRIGATION
Labeler
Baxter Healthcare Company
Application
NDA017867
Marketing category
NDA
Marketing start
1980-05-30
Substance
SODIUM CHLORIDE
Active strength
900 mg/100mL
Pharmacologic classes
Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Chloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM CHLORIDE900 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii451W47IQ8X
Rxcui486515

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
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
0338-0047-242021-08-03C16284748780-1c7ccaba7-0eee-fd44-e053-dadaa90aa01b0.9% Sodium Chloride Irrigation, USP in ARTHROMATIC Plastic Container
0338-0047-272021-08-03C16284748780-1c7ccaba7-0eee-fd44-e053-dadaa90aa01b0.9% Sodium Chloride Irrigation, USP in ARTHROMATIC Plastic Container
0338-0047-292021-08-03C16284748780-1c7ccaba7-0eee-fd44-e053-dadaa90aa01b0.9% Sodium Chloride Irrigation, USP in ARTHROMATIC Plastic Container
0338-0047-442021-08-03C16284748780-1c7ccaba7-0ee8-fd44-e053-dadaa90aa01b886f889b-f3cf-4197-b307-6cfa88c89436
0338-0047-462021-08-03C16284748780-1c7ccaba7-0ee8-fd44-e053-dadaa90aa01b886f889b-f3cf-4197-b307-6cfa88c89436
0338-0047-472021-08-03C16284748780-1c7ccaba7-0ee8-fd44-e053-dadaa90aa01b886f889b-f3cf-4197-b307-6cfa88c89436
0338-0047-242021-07-23C16284748780-1c7ccaba7-0eee-fd44-e053-dadaa90aa01b0.9% Sodium Chloride Irrigation, USP in ARTHROMATIC Plastic Container
0338-0047-272021-07-23C16284748780-1c7ccaba7-0eee-fd44-e053-dadaa90aa01b0.9% Sodium Chloride Irrigation, USP in ARTHROMATIC Plastic Container
0338-0047-292021-07-23C16284748780-1c7ccaba7-0eee-fd44-e053-dadaa90aa01b0.9% Sodium Chloride Irrigation, USP in ARTHROMATIC Plastic Container
0338-0047-442021-07-23C16284748780-1c7ccaba7-0ee8-fd44-e053-dadaa90aa01b886f889b-f3cf-4197-b307-6cfa88c89436
0338-0047-462021-07-23C16284748780-1c7ccaba7-0ee8-fd44-e053-dadaa90aa01b886f889b-f3cf-4197-b307-6cfa88c89436
0338-0047-472021-07-23C16284748780-1c7ccaba7-0ee8-fd44-e053-dadaa90aa01b886f889b-f3cf-4197-b307-6cfa88c89436

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-0047-24Sodium Chloride14 in 1 CARTONIRRIGANT1412
0338-0047-24Sodium Chloride1000 mL in 1 BAGIRRIGANT100012
0338-0047-27Sodium Chloride4 in 1 CARTONIRRIGANT412
0338-0047-27Sodium Chloride3000 mL in 1 BAGIRRIGANT300012
0338-0047-29Sodium Chloride2 in 1 CARTONIRRIGANT212
0338-0047-29Sodium Chloride5000 mL in 1 BAGIRRIGANT500012
0338-0047-44Sodium Chloride14 in 1 CARTONIRRIGANT1412
0338-0047-44Sodium Chloride1000 mL in 1 BAGIRRIGANT100012
0338-0047-46Sodium Chloride6 in 1 CARTONIRRIGANT612
0338-0047-46Sodium Chloride2000 mL in 1 BAGIRRIGANT200012
0338-0047-47Sodium Chloride3000 mL in 1 BAGIRRIGANT300012
0338-0047-47Sodium Chloride4 in 1 CARTONIRRIGANT412

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-0047-24ML - Milliliter0338-004745b93957-3681-4dc2-9edc-c8787f6b4ef712012-07-24
0338-0047-27ML - Milliliter0338-004756cac658-e298-4812-9636-755b666d466112012-07-24
0338-0047-29ML - Milliliter0338-00477ed23c15-fa2f-4d1f-8abe-14361c3d8f1512012-07-24
0338-0047-44ML - Milliliter0338-0047a3f4a256-ec66-49e9-b50b-2852d8bfb93312013-02-13
0338-0047-46ML - Milliliter0338-0047c80da737-805e-4c01-a582-600654b8014212013-02-13
0338-0047-47ML - Milliliter0338-0047bc6c0f3f-1fc2-4a99-aa2a-964790c69e5c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XSODIUM CHLORIDE IRRIGANT [BAXTER HEALTHCARE CORPORATION]4
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XSODIUM CHLORIDE IRRIGANT [BAXTER HEALTHCARE CORPORATION]4
CHLORIDE IONACTIVE MOIETYQ32ZN48698SODIUM CHLORIDE IRRIGANT [BAXTER HEALTHCARE CORPORATION]4
CHLORIDE IONACTIVE MOIETYQ32ZN48698SODIUM CHLORIDE IRRIGANT [BAXTER HEALTHCARE CORPORATION]4
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM CHLORIDE IRRIGANT [BAXTER HEALTHCARE CORPORATION]4
WaterINACTIVE INGREDIENT059QF0KO0RSODIUM CHLORIDE IRRIGANT [BAXTER HEALTHCARE CORPORATION]4
SODIUM CATIONACTIVE INGREDIENTLYR4M0NH37NINEPERCENT (0.9% SALINE) INJECTION, SOLUTION [US SPECIALTY FORMULATIONS LLC]2
SODIUM CATIONACTIVE MOIETYLYR4M0NH37NINEPERCENT (0.9% SALINE) INJECTION, SOLUTION [US SPECIALTY FORMULATIONS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-0047SODIUM CHLORIDE IRRIGANT [BAXTER HEALTHCARE COMPANY]11Current NDC, Legacy NDC, 6 package rows20250315_886f889b-f3cf-4197-b307-6cfa88c89436.zip
0338-0047SODIUM CHLORIDE IRRIGANT [BAXTER HEALTHCARE CORPORATION]11Current NDC, Legacy NDC, 6 package rows20250515_05dee566-7b82-4216-8a6b-765d2b4d9dc7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
486515sodium chloride 0.9 % Irrigation SolutionPSN05dee566-7b82-4216-8a6b-765d2b4d9dc712
486515sodium chloride 0.9 % Irrigation SolutionPSN886f889b-f3cf-4197-b307-6cfa88c8943612
486515sodium chloride 0.154 MEQ/ML Irrigation SolutionSCD05dee566-7b82-4216-8a6b-765d2b4d9dc712
486515sodium chloride 0.154 MEQ/ML Irrigation SolutionSCD886f889b-f3cf-4197-b307-6cfa88c8943612
486515NaCl 0.154 MEQ/ML Irrigation SolutionSY05dee566-7b82-4216-8a6b-765d2b4d9dc712
486515NaCl 0.154 MEQ/ML Irrigation SolutionSY886f889b-f3cf-4197-b307-6cfa88c8943612
486515sodium chloride 0.9 % Irrigation SolutionSY05dee566-7b82-4216-8a6b-765d2b4d9dc712
486515sodium chloride 0.9 % Irrigation SolutionSY886f889b-f3cf-4197-b307-6cfa88c8943612
1807632sodium chloride 0.9 % in 100 ML InjectionPSN079ab69e-6972-4b6e-e054-00144ff8d46c2
1807632100 ML sodium chloride 9 MG/ML InjectionSCD079ab69e-6972-4b6e-e054-00144ff8d46c2
1807632100 ML NaCl 9 MG/ML InjectionSY079ab69e-6972-4b6e-e054-00144ff8d46c2
1807632sodium chloride 0.9 % per 100 ML InjectionSY079ab69e-6972-4b6e-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-0047-240033800472414 in 1 CARTONHistorical
0338-0047-27003380047274 BAG in 1 CARTON (0338-0047-27) / 3000 mL in 1 BAG4 bag1980-05-300000-00-00NoNoCurrent
0338-0047-29003380047292 BAG in 1 CARTON (0338-0047-29) / 5000 mL in 1 BAG2 bag1980-05-300000-00-00NoNoCurrent
0338-0047-440033800474414 BAG in 1 CARTON (0338-0047-44) / 1000 mL in 1 BAG14 bag1980-05-300000-00-00NoNoCurrent
0338-0047-46003380047466 BAG in 1 CARTON (0338-0047-46) / 2000 mL in 1 BAG6 bag1980-05-300000-00-00NoNoCurrent
0338-0047-47003380047474 BAG in 1 CARTON (0338-0047-47) / 3000 mL in 1 BAG4 bag1980-05-300000-00-00NoNoCurrent